Manager, Regulatory Operations
Otsuka Pharmaceutical Companies (U.S.) · United States · 1 mo ago
RemoteRemoteLegal$108k/yrFull-time
We need to output HTML fragment with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Remove boilerplate, navigation, legal, EEO, etc. Also remove application instructions, etc.
We need to parse the job posting.
Job Summary: "The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency."
Job Description: many bullet-like sentences.
Qualifications: Required: list; Preferred: list.
Competencies: list of competencies.
Pay: "Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: ..."
Benefits: "Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits."
Schedule: Not explicitly mentioned. There's no schedule info. So we should not include Schedule section.
We need sections: About the role (maybe from Job Summary?), Responsibilities (from Job Description), Requirements (maybe Required qualifications?), Qualifications (maybe Preferred?), Skills (maybe competencies?), Benefits, Pay.
We must not repeat job title as heading. Use
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Remove boilerplate, navigation, legal, EEO, etc. Also remove application instructions, etc.
We need to parse the job posting.
Job Summary: "The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency."
Job Description: many bullet-like sentences.
Qualifications: Required: list; Preferred: list.
Competencies: list of competencies.
Pay: "Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: ..."
Benefits: "Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits."
Schedule: Not explicitly mentioned. There's no schedule info. So we should not include Schedule section.
We need sections: About the role (maybe from Job Summary?), Responsibilities (from Job Description), Requirements (maybe Required qualifications?), Qualifications (maybe Preferred?), Skills (maybe competencies?), Benefits, Pay.
We must not repeat job title as heading. Use for each section heading.
We need to preserve all substantive information, not invent or summarize away detail. Use - for any list of duties/requirements/benefits, and
for prose.
We need to decide what goes where.
Let's extract:
Job Summary: could be "About the role". Use
About the role
then with that sentence.
Job Description: list of responsibilities. Many sentences. We'll turn each sentence into
- maybe. But need to preserve all details. Could group into
- each responsibility.
Let's extract responsibilities sentences:
- As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts
- Ensures assigned submissions are made with quality, on-time, and within established budgets
- Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions
- Liaise with affiliates for coordinating and publishing defined content
- Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules
- Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements
- Ensures submission and archival activities
- Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards
- Oversees project team members for assigned submissions, including work assignments to vendor partners
- Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)
- Develops and maintains assigned regulatory operations work instructions
- Establishes and builds collaborative relationships with colleagues
- Responsible for organizing and maintaining regulatory files
- Provides regulatory publishing guidance to other departments / functions
That's a lot. We'll put each as
- .
Now Qualifications Required: list:
- Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
- Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
- Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
- Demonstrated performance in managing and producing time-intensive deliverables
- Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
- Knowledge in developing processes across multiple departments/divisions that leverage technology
- Recent experience with NDAs / MAAs is essential
Preferred:
- Demonstrated performance in managing and producing quality time-intensive deliverables (some duplication but keep)
- Strong staff management skills
- Proven ability to solve complex issues through innovative problem solving
- Well defined written and oral communication skills
- Knowledge how/when to apply organizational policy or procedures to a variety of situations
- Demonstrated flexibility in dealing with change and diversity
- Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
- Successful engagement in multiple initiatives simultaneously
- Certification (such as Regulatory Affairs Professionals Society (RAPS))
- Prior project management experience
Competencies: list:
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
We could put competencies under Skills section.
Now Pay: we have a paragraph with pay range. We'll put under
Pay
with that text.
Benefits: we have a paragraph. We'll put under
Benefits
with that text.
We need to avoid duplication: The Required and Preferred both have "Demonstrated performance in managing and producing quality time-intensive deliverables" (similar). We'll keep both as separate list items.
Now we need to decide which sections to include: About the role, Responsibilities, Requirements (maybe Required qualifications), Qualifications (maybe Preferred), Skills (competencies), Benefits, Pay.
We could combine Required and Qualifications into one "Requirements" section with sublists? But instructions: use headings for sections; we can have multiple sections. We'll include both Required and Preferred as separate sections? The headings list includes Requirements and Qualifications. So we can put Required under Requirements, Preferred under Qualifications. That seems appropriate.
Now we need to ensure we don't include filler like "commensurate with experience". Not present.
Now produce HTML fragment.
We must not include or . Just the fragment.
Let's craft:
About the role
The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency.
Responsibilities
- As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts
- Ensures assigned submissions are made with quality, on-time, and within established budgets
- Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions
- Liaise with affiliates for coordinating and publishing defined content
- Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules
- Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements
- Ensures submission and archival activities
- Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards
- Oversees project team members for assigned submissions, including work assignments to vendor partners
- Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)
- Develops and maintains assigned regulatory operations work instructions
- Establishes and builds collaborative relationships with colleagues
- Responsible for organizing and maintaining regulatory files
- Provides regulatory publishing guidance to other departments / functions
Requirements
- Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
- Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
- Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
- Demonstrated performance in managing and producing time-intensive deliverables
- Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
- Knowledge in developing processes across multiple departments/divisions that leverage technology
- Recent experience with NDAs / MAAs is essential
Qualifications
- Demonstrated performance in managing and producing quality time-intensive deliverables
- Strong staff management skills
- Proven ability to solve complex issues through innovative problem solving
- Well defined written and oral communication skills
- Knowledge how/when to apply organizational policy or procedures to a variety of situations
- Demonstrated flexibility in dealing with change and diversity
- Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
- Successful engagement in multiple initiatives simultaneously
- Certification (such as Regulatory Affairs Professionals Society (RAPS))
- Prior project management experience
Skills
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
Benefits
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Pay
Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The
- for any list of duties/requirements/benefits, and
for prose. We need to decide what goes where. Let's extract: Job Summary: could be "About the role". Use
About the role
thenwith that sentence. Job Description: list of responsibilities. Many sentences. We'll turn each sentence into
- maybe. But need to preserve all details. Could group into
- each responsibility. Let's extract responsibilities sentences: - As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts - Ensures assigned submissions are made with quality, on-time, and within established budgets - Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions - Liaise with affiliates for coordinating and publishing defined content - Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules - Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements - Ensures submission and archival activities - Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards - Oversees project team members for assigned submissions, including work assignments to vendor partners - Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports) - Develops and maintains assigned regulatory operations work instructions - Establishes and builds collaborative relationships with colleagues - Responsible for organizing and maintaining regulatory files - Provides regulatory publishing guidance to other departments / functions That's a lot. We'll put each as
- .
Now Qualifications Required: list:
- Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
- Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
- Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
- Demonstrated performance in managing and producing time-intensive deliverables
- Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
- Knowledge in developing processes across multiple departments/divisions that leverage technology
- Recent experience with NDAs / MAAs is essential
Preferred:
- Demonstrated performance in managing and producing quality time-intensive deliverables (some duplication but keep)
- Strong staff management skills
- Proven ability to solve complex issues through innovative problem solving
- Well defined written and oral communication skills
- Knowledge how/when to apply organizational policy or procedures to a variety of situations
- Demonstrated flexibility in dealing with change and diversity
- Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
- Successful engagement in multiple initiatives simultaneously
- Certification (such as Regulatory Affairs Professionals Society (RAPS))
- Prior project management experience
Competencies: list:
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
We could put competencies under Skills section.
Now Pay: we have a paragraph with pay range. We'll put under
Pay
with that text. Benefits: we have a paragraph. We'll put under
Benefits
with that text. We need to avoid duplication: The Required and Preferred both have "Demonstrated performance in managing and producing quality time-intensive deliverables" (similar). We'll keep both as separate list items. Now we need to decide which sections to include: About the role, Responsibilities, Requirements (maybe Required qualifications), Qualifications (maybe Preferred), Skills (competencies), Benefits, Pay. We could combine Required and Qualifications into one "Requirements" section with sublists? But instructions: use headings for sections; we can have multiple sections. We'll include both Required and Preferred as separate sections? The headings list includes Requirements and Qualifications. So we can put Required under Requirements, Preferred under Qualifications. That seems appropriate. Now we need to ensure we don't include filler like "commensurate with experience". Not present. Now produce HTML fragment. We must not include or . Just the fragment. Let's craft:
About the role
The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency.
Responsibilities
- As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts
- Ensures assigned submissions are made with quality, on-time, and within established budgets
- Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions
- Liaise with affiliates for coordinating and publishing defined content
- Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules
- Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements
- Ensures submission and archival activities
- Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards
- Oversees project team members for assigned submissions, including work assignments to vendor partners
- Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)
- Develops and maintains assigned regulatory operations work instructions
- Establishes and builds collaborative relationships with colleagues
- Responsible for organizing and maintaining regulatory files
- Provides regulatory publishing guidance to other departments / functions
Requirements
- Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
- Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
- Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
- Demonstrated performance in managing and producing time-intensive deliverables
- Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
- Knowledge in developing processes across multiple departments/divisions that leverage technology
- Recent experience with NDAs / MAAs is essential
Qualifications
- Demonstrated performance in managing and producing quality time-intensive deliverables
- Strong staff management skills
- Proven ability to solve complex issues through innovative problem solving
- Well defined written and oral communication skills
- Knowledge how/when to apply organizational policy or procedures to a variety of situations
- Demonstrated flexibility in dealing with change and diversity
- Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
- Successful engagement in multiple initiatives simultaneously
- Certification (such as Regulatory Affairs Professionals Society (RAPS))
- Prior project management experience
Skills
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
Benefits
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Pay
Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The