Senior Manager, Global Clinical Regulatory Lead
PTC Therapeutics, Inc. · New Jersey, United States · 1 mo ago
Hybrid$130k–$165k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes description summary and description. We need to use for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to extract content.
Let's parse.
Job Description Summary: paragraph about role responsibilities.
Job Description: more detailed responsibilities.
Qualifications: list of qualifications.
Other sections: Travel requirements, hybrid role location, Expected Base Salary Range, benefits mention (short- and long-term incentives, medical, dental, vision, retirement savings). Also maybe "Skills" could be derived from qualifications but we can put under Qualifications or Skills. The instruction: Use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections have content.
We have:
- About the role: could be the summary paragraph.
- Responsibilities: the detailed job description bullet points (though not bullet list originally but sentences). We can convert to
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to extract content.
Let's parse.
Job Description Summary: paragraph about role responsibilities.
Job Description: more detailed responsibilities.
Qualifications: list of qualifications.
Other sections: Travel requirements, hybrid role location, Expected Base Salary Range, benefits mention (short- and long-term incentives, medical, dental, vision, retirement savings). Also maybe "Skills" could be derived from qualifications but we can put under Qualifications or Skills. The instruction: Use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections have content.
We have:
- About the role: could be the summary paragraph.
- Responsibilities: the detailed job description bullet points (though not bullet list originally but sentences). We can convert to - .
- Requirements: maybe the qualifications? But they also have Qualifications heading. Could treat Requirements as "Experience/education" and Qualifications as "skills"? But we have both headings allowed. We need to avoid duplication. Perhaps we put education/experience under Requirements, and skills/abilities under Qualifications or Skills. However the posting includes a "Qualifications" section with bullet-like list. So we can use
Qualifications
for that list.
We also have Pay: Expected Base Salary Range $130,000 - $164,600 plus mention of short- and long-term incentives. So we can create Pay section.
Benefits: mention medical, dental, vision, retirement savings plans. Also short- and long-term incentives maybe part of compensation but could be Benefits. We'll include Benefits.
Schedule: hybrid role to Warren, NJ, travel up to 5%. Could be Schedule? Actually schedule could be hybrid and travel. We'll put Schedule.
We must not include sections with placeholder text. All have real content.
We must not repeat job title as heading. Not include Job ID.
We must remove boilerplate like EEO statement, etc.
We must preserve all substantive information; not invent or summarize away detail. So we need to keep details like responsibilities sentences, qualifications list, travel, location, salary range, incentives, benefits.
We need to format as HTML fragment only, no or . Use headings,
for prose,
- for lists.
We need to ensure we don't duplicate content.
Let's extract responsibilities from Job Description Summary and Job Description.
Summary: "The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing strategic and operational direction for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the US as applicable. This role includes responsibility for support of global clinical trials, regional registrations and life cycle management regulatory activities. This individual supports the Global Regulatory Lead on their assigned products. This position collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-functional teams on assigned projects. The role is responsible for overseeing the IND submission in the US, as well as for clinical trials applications for the rest of world. Additionally, this role supports the GRL to ensure that regional regulatory strategies are executed in compliance with current, applicable regulations and standards. This position works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers. The Senior Manager, Regulatory Affairs US ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate."
Then Job Description paragraph: "Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives.Provides regulatory support to the Global Pharmacovigilance (PV) organization and regional/country representatives as necessary to ensure that PTC’s PV obligations within the region are met.Perform other tasks and assignments as needed and specified by management.Works closely with GRL in the preparation of Global Regulatory Strategy for assigned projects:Maintain current knowledge of relevant regulations, including proposed and final rules as well as updated regulatory guidance’sPrepare global regulatory strategy for drugs and gene therapies through conducting research, preparation of labeling documents, and additional regulatory submissions.Analyze clinical, non-clinical and CMC development work in context with global regulatory guidance to develop global regulatory strategies.Prepare CCDS (company core data sheet), US-PI and SmPCPrepare and review regulatory submissions for domestic or international projects, such as Rare Pediatric Disease Designation (RPDD) applications, Orphan Drug Designation (ODD) applications, Annual Reports, and Development Safety Update Reports (DSURs), Scientific Advice briefing books, pre-IND, IND, Briefing Books, and MAA/BLA/NDAsPerforms other tasks and assignments as needed and specified by management. Clinical Trial Applications (CTAs) Initiate and execute CTA/CTNs in US, EU, and globally by keeping up to date with regulations and critically analyzing the interactions with health authorities to ensure that any outstanding issues are addressedLiaise and attend essential meetings between Contract Research Organizations (CROs) and PTC regulatory team to retrieve documents as needed for submissions to Health Authorities internationally.Align with CROs, IRL and GRLs on timelines for development and submission of CTAs"
We need to split into list items. Could break by sentences. We'll create
- each sentence.
But we must preserve all substantive information; not lose any detail. We'll keep the content as is, just split.
Now Qualifications: list:
- Bachelor’s degree in life science field and a minimum of 5 years experience in the Pharma/Bio Industry, an MS, PhD, or PharmD with a minimum of 3 years of experience in Regulatory Affairs.
- Knowledge of relevant, regional regulatory guidelines and requirements with the ability to interpret these as it applies to assigned projects.
- Demonstrated, hands-on experience managing and submitting clinical trial applications, leading the activities to support responses to queries from health agencies across all phases of development.
- Ability to support the Global Regulatory Lead as requested, with research and selected tasks outside of clinical trial filings.
- Demonstrated track record of successfully building stakeholder relationships with cross-functional teams
- Excellent verbal and written communication
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to influence without direct authority.
- Fluent in English (verbal and written). Other languages considered an advantage.
- Travel requirements: Up to 5% travel
- This is a hybrid role to Warren, NJ
But travel and hybrid role maybe better under Schedule. We'll keep them there.
Pay: Expected Base Salary Range $130,000 - $164,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
Benefits: All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
Schedule: Hybrid role to Warren, NJ; Up to 5% travel.
We need to avoid duplication: Travel appears both in Qualifications and Schedule; we should keep only once. Probably better to put travel under Schedule, not Qualifications. So remove travel from Qualifications list.
Similarly hybrid role location under Schedule.
Thus Qualifications list excludes travel and hybrid.
Now we need to ensure we don't include boilerplate like EEO statement, etc.
Now produce HTML.
Structure:
About the role
... summary paragraph ...
Responsibilities
- ... each sentence ...
...
Qualifications
- ... each qualification bullet ...
...
Pay
... salary range and incentives ...
Benefits
... medical, dental, vision, retirement savings ...
Schedule
Hybrid role based in Warren, NJ with up to 5% travel.
Check that we haven't missed any substantive info: The summary paragraph included many responsibilities; we moved them to Responsibilities list. Ensure we didn't lose any detail: The summary paragraph includes: providing strategic and operational direction for planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the US as applicable; support of global clinical trials, regional registrations and life cycle management regulatory activities; supports the Global Regulatory Lead on their assigned products; collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-functional teams on assigned projects; overseeing the IND submission in the US, as well as for clinical trials applications for the rest of world; supports the GRL to ensure that regional regulatory strategies are executed in compliance with current, applicable regulations and standards; works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers; ensures adherence to relevant regulatory requirements and company SOPs as appropriate.
We need to include all those points in Responsibilities list.
Now the Job Description paragraph includes many more items: Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations. Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives. Provides regulatory support to the Global Pharmacovigilance (PV) organization and regional/country representatives as necessary to ensure that PTC’s PV obligations within the region are met. Perform other tasks and assignments as needed and specified by management. Works closely with GRL in the preparation of Global Regulatory Strategy for assigned projects: Maintain current knowledge of relevant regulations, including proposed and final rules as well as updated regulatory guidance’s Prepare global regulatory strategy for drugs and gene therapies through conducting research, preparation of labeling documents, and additional regulatory submissions. Analyze clinical, non-clinical and CMC development work in context with global regulatory guidance to develop global regulatory strategies. Prepare CCDS (company core data sheet), US-PI and SmPC Prepare and review regulatory submissions for domestic or international projects, such as Rare Pediatric Disease Designation (RPDD) applications, Orphan Drug Designation (ODD) applications, Annual Reports, and Development Safety Update Reports (DSURs), Scientific Advice briefing books, pre-IND, IND, Briefing Books, and MAA/BLA/NDAs Performs other tasks and assignments as needed and specified by management. Clinical Trial Applications (CTAs) Initiate and execute CTA/CTNs in US, EU, and globally by keeping up to date with regulations and critically analyzing the interactions with health authorities to ensure that any outstanding issues are addressed Liaise and attend essential meetings between Contract Research Organizations (CROs) and PTC regulatory team to retrieve documents as needed for submissions to Health Authorities internationally. Align with CROs, IRL and GRLs on timelines for development and submission of CTAs
We need to split into sensible list items. Some sentences are long with colons; we can keep as one item.
Let's create list items:
- Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.
- Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives.
- Provides regulatory support to the Global
Qualifications
for that list. We also have Pay: Expected Base Salary Range $130,000 - $164,600 plus mention of short- and long-term incentives. So we can create Pay section. Benefits: mention medical, dental, vision, retirement savings plans. Also short- and long-term incentives maybe part of compensation but could be Benefits. We'll include Benefits. Schedule: hybrid role to Warren, NJ, travel up to 5%. Could be Schedule? Actually schedule could be hybrid and travel. We'll put Schedule. We must not include sections with placeholder text. All have real content. We must not repeat job title as heading. Not include Job ID. We must remove boilerplate like EEO statement, etc. We must preserve all substantive information; not invent or summarize away detail. So we need to keep details like responsibilities sentences, qualifications list, travel, location, salary range, incentives, benefits. We need to format as HTML fragment only, no or . Useheadings,
for prose,
- for lists.
We need to ensure we don't duplicate content.
Let's extract responsibilities from Job Description Summary and Job Description.
Summary: "The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing strategic and operational direction for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the US as applicable. This role includes responsibility for support of global clinical trials, regional registrations and life cycle management regulatory activities. This individual supports the Global Regulatory Lead on their assigned products. This position collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-functional teams on assigned projects. The role is responsible for overseeing the IND submission in the US, as well as for clinical trials applications for the rest of world. Additionally, this role supports the GRL to ensure that regional regulatory strategies are executed in compliance with current, applicable regulations and standards. This position works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers. The Senior Manager, Regulatory Affairs US ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate."
Then Job Description paragraph: "Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives.Provides regulatory support to the Global Pharmacovigilance (PV) organization and regional/country representatives as necessary to ensure that PTC’s PV obligations within the region are met.Perform other tasks and assignments as needed and specified by management.Works closely with GRL in the preparation of Global Regulatory Strategy for assigned projects:Maintain current knowledge of relevant regulations, including proposed and final rules as well as updated regulatory guidance’sPrepare global regulatory strategy for drugs and gene therapies through conducting research, preparation of labeling documents, and additional regulatory submissions.Analyze clinical, non-clinical and CMC development work in context with global regulatory guidance to develop global regulatory strategies.Prepare CCDS (company core data sheet), US-PI and SmPCPrepare and review regulatory submissions for domestic or international projects, such as Rare Pediatric Disease Designation (RPDD) applications, Orphan Drug Designation (ODD) applications, Annual Reports, and Development Safety Update Reports (DSURs), Scientific Advice briefing books, pre-IND, IND, Briefing Books, and MAA/BLA/NDAsPerforms other tasks and assignments as needed and specified by management. Clinical Trial Applications (CTAs) Initiate and execute CTA/CTNs in US, EU, and globally by keeping up to date with regulations and critically analyzing the interactions with health authorities to ensure that any outstanding issues are addressedLiaise and attend essential meetings between Contract Research Organizations (CROs) and PTC regulatory team to retrieve documents as needed for submissions to Health Authorities internationally.Align with CROs, IRL and GRLs on timelines for development and submission of CTAs"
We need to split into list items. Could break by sentences. We'll create
- each sentence.
But we must preserve all substantive information; not lose any detail. We'll keep the content as is, just split.
Now Qualifications: list:
- Bachelor’s degree in life science field and a minimum of 5 years experience in the Pharma/Bio Industry, an MS, PhD, or PharmD with a minimum of 3 years of experience in Regulatory Affairs.
- Knowledge of relevant, regional regulatory guidelines and requirements with the ability to interpret these as it applies to assigned projects.
- Demonstrated, hands-on experience managing and submitting clinical trial applications, leading the activities to support responses to queries from health agencies across all phases of development.
- Ability to support the Global Regulatory Lead as requested, with research and selected tasks outside of clinical trial filings.
- Demonstrated track record of successfully building stakeholder relationships with cross-functional teams
- Excellent verbal and written communication
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to influence without direct authority.
- Fluent in English (verbal and written). Other languages considered an advantage.
- Travel requirements: Up to 5% travel
- This is a hybrid role to Warren, NJ
But travel and hybrid role maybe better under Schedule. We'll keep them there.
Pay: Expected Base Salary Range $130,000 - $164,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
Benefits: All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
Schedule: Hybrid role to Warren, NJ; Up to 5% travel.
We need to avoid duplication: Travel appears both in Qualifications and Schedule; we should keep only once. Probably better to put travel under Schedule, not Qualifications. So remove travel from Qualifications list.
Similarly hybrid role location under Schedule.
Thus Qualifications list excludes travel and hybrid.
Now we need to ensure we don't include boilerplate like EEO statement, etc.
Now produce HTML.
Structure:
About the role
... summary paragraph ...
Responsibilities
- ... each sentence ... ...
Qualifications
- ... each qualification bullet ... ...
Pay
... salary range and incentives ...
Benefits
... medical, dental, vision, retirement savings ...
Schedule
Hybrid role based in Warren, NJ with up to 5% travel.
Check that we haven't missed any substantive info: The summary paragraph included many responsibilities; we moved them to Responsibilities list. Ensure we didn't lose any detail: The summary paragraph includes: providing strategic and operational direction for planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the US as applicable; support of global clinical trials, regional registrations and life cycle management regulatory activities; supports the Global Regulatory Lead on their assigned products; collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-functional teams on assigned projects; overseeing the IND submission in the US, as well as for clinical trials applications for the rest of world; supports the GRL to ensure that regional regulatory strategies are executed in compliance with current, applicable regulations and standards; works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers; ensures adherence to relevant regulatory requirements and company SOPs as appropriate. We need to include all those points in Responsibilities list. Now the Job Description paragraph includes many more items: Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations. Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives. Provides regulatory support to the Global Pharmacovigilance (PV) organization and regional/country representatives as necessary to ensure that PTC’s PV obligations within the region are met. Perform other tasks and assignments as needed and specified by management. Works closely with GRL in the preparation of Global Regulatory Strategy for assigned projects: Maintain current knowledge of relevant regulations, including proposed and final rules as well as updated regulatory guidance’s Prepare global regulatory strategy for drugs and gene therapies through conducting research, preparation of labeling documents, and additional regulatory submissions. Analyze clinical, non-clinical and CMC development work in context with global regulatory guidance to develop global regulatory strategies. Prepare CCDS (company core data sheet), US-PI and SmPC Prepare and review regulatory submissions for domestic or international projects, such as Rare Pediatric Disease Designation (RPDD) applications, Orphan Drug Designation (ODD) applications, Annual Reports, and Development Safety Update Reports (DSURs), Scientific Advice briefing books, pre-IND, IND, Briefing Books, and MAA/BLA/NDAs Performs other tasks and assignments as needed and specified by management. Clinical Trial Applications (CTAs) Initiate and execute CTA/CTNs in US, EU, and globally by keeping up to date with regulations and critically analyzing the interactions with health authorities to ensure that any outstanding issues are addressed Liaise and attend essential meetings between Contract Research Organizations (CROs) and PTC regulatory team to retrieve documents as needed for submissions to Health Authorities internationally. Align with CROs, IRL and GRLs on timelines for development and submission of CTAs We need to split into sensible list items. Some sentences are long with colons; we can keep as one item. Let's create list items: - Collaborates and attends meetings with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations. - Ensures that drug and biologic products distributed within the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives. - Provides regulatory support to the Global
- each sentence.
But we must preserve all substantive information; not lose any detail. We'll keep the content as is, just split.
Now Qualifications: list:
- Bachelor’s degree in life science field and a minimum of 5 years experience in the Pharma/Bio Industry, an MS, PhD, or PharmD with a minimum of 3 years of experience in Regulatory Affairs.
- Knowledge of relevant, regional regulatory guidelines and requirements with the ability to interpret these as it applies to assigned projects.
- Demonstrated, hands-on experience managing and submitting clinical trial applications, leading the activities to support responses to queries from health agencies across all phases of development.
- Ability to support the Global Regulatory Lead as requested, with research and selected tasks outside of clinical trial filings.
- Demonstrated track record of successfully building stakeholder relationships with cross-functional teams
- Excellent verbal and written communication
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to influence without direct authority.
- Fluent in English (verbal and written). Other languages considered an advantage.
- Travel requirements: Up to 5% travel
- This is a hybrid role to Warren, NJ
But travel and hybrid role maybe better under Schedule. We'll keep them there.
Pay: Expected Base Salary Range $130,000 - $164,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
Benefits: All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
Schedule: Hybrid role to Warren, NJ; Up to 5% travel.
We need to avoid duplication: Travel appears both in Qualifications and Schedule; we should keep only once. Probably better to put travel under Schedule, not Qualifications. So remove travel from Qualifications list.
Similarly hybrid role location under Schedule.
Thus Qualifications list excludes travel and hybrid.
Now we need to ensure we don't include boilerplate like EEO statement, etc.
Now produce HTML.
Structure: