Associate, Regulatory Affairs
for section headings.
We need to use - for any list of duties/requirements/benefits, and
for prose.
We need to include sections only when posting has real specific content.
We need to avoid filler like "commensurate with experience", "not specified", etc.
We need to output only HTML fragment.
Let's extract content.
The posting starts: "Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. For the Builders, Innovators, and Doers — This Is Your Place If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally. Why builders choose us: Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide. Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period. A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity. A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution. A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation. If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here."
This is like an "About the role" or company overview. Could be "About the role" or maybe "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can put company overview under "About the role". Or maybe "About the role" is appropriate.
Next: "Job Description: To provide foundational regulatory support to project teams by assisting with the preparation, maintenance, and submission of regulatory documentation while developing knowledge of regulatory requirements, guidance, and internal processes. The Associate role builds regulatory competency and reliability by executing defined tasks to ensure accuracy, compliance, and timely delivery of regulatory activities."
Then bullet list of duties: "Regulatory Submissions (CMC) Assist with preparation, compilation, and filing of regulatory submissions (e.g., Amendments, Annual Reports, DMF updates) Gather and organize source documentation from SMEs to support submission readiness Draft routine scientific rationales or technical sections using established templates Support responses to regulatory agency questions with guidance from senior staff Operations / Systems Support electronic publishing and filing activities following established procedures Perform quality checks to ensure documents meet regulatory and company formatting requirements Project Support Provide tactical regulatory support to cross-functional teams Track deliverables and timelines; escalate risks or delays as identified Technical Guidance Develop working knowledge of applicable regulatory requirements and systems Seek guidance appropriately and implement feedback into regulatory deliverables Compliance Support compliance activities, audits, and inspections through document preparation and record maintenance Assist in review of change controls and external communications for regulatory accuracy Strategy Development Support implementation of defined regulatory strategies through assigned deliverables Interfacing Coordinate requests and information flow with internal teams and approved external partners"
These are responsibilities/duties.
Then "Required: Associate’s degree – If no degree + 2 years relevant experience. Preferred: Other languages: French (Canadian) and/or Spanish (desired) Position requires excellent verbal and written communication skills in English. ERP/MRP system (SAP preferred) Interpersonal skills must include clear and concise verbal and written communication to others within facility. This is extended to external communication with government agencies, consultants, and contract clients as defined by Regulatory management. Position must be able to assist with resolution negotiations that impact Regulatory compliance by creating reasoned and rationale strategies to guide the organization. Must demonstrate a collaborative work style, with an ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational and communication skills. Working Environment: Operates in a routine environment with simple rules and detailed instruction. Maintains disciplined, self-motivated remote work practices, ensures timely deliverables, and attends required web-based meetings. Manages conflict, influences outcomes, and escalates issues as appropriate. Develops an understanding of product and project issues and learns to identify relevant regulations and external guidance. Assists in problem-solving by providing input, drafting recommendations, and supporting proposed actions to address regulatory issues. Be able to lift 20 lbs. unassisted. Prolonged Sitting Location: Spokane, WA — Remote, Full- -Time Shift: Weekday Days,M-F"
Then "Compensation & Benefits That Start on Day One — Because Your Well Being Matters Hiring Wage: $32.01 - $43.30, with opportunities for growth, promotion, and annual raises. At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success. Starting on your first day, you receive: Medical, Dental & Vision coverage Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D Insurance Short-Term & Long-Term Disability Insurance Employee Assistance Program"
Then "Unlock Your Potential If you’re seeking a dynamic and rewarding career, we welcome your application today. Apply online: Careers - Jubilant HollisterStier Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require assistance applying for a position, contact: JHS-TalentAcquisition@jubl.com Our Promise: Caring, Sharing, Growing We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society."
We need to remove EEO/AA, application instructions, contact, etc. Also remove duplicated lines.
We need to keep substantive info: company overview, job description, responsibilities, required qualifications, preferred qualifications, working environment, location, shift, compensation, benefits.
We need to decide sections.
Possible sections:
- About the role (company overview and why builders choose us)
- Responsibilities (list of duties)
- Requirements (required qualifications)
- Qualifications (maybe preferred qualifications)
- Skills (maybe communication, organizational, etc.)
- Benefits (list)
- Pay (hiring wage)
- Schedule (location, shift, remote, full-time)
We need to avoid filler like "Opportunities for growth, promotion, and annual raises" maybe belongs in Benefits or Pay? It's part of compensation description.
We need to ensure we don't create sections with placeholder text.
Let's extract each.
**About the role**: The initial paragraph about company and why builders choose us. Could be combined.
We'll produce a
with that prose.
**Responsibilities**: The bullet list under Job Description and the enumerated duties. We'll make a
- for each duty.
List them:
- Assist with preparation, compilation, and filing of regulatory submissions (e.g., Amendments, Annual Reports, DMF updates)
- Gather and organize source documentation from SMEs to support submission readiness
- Draft routine scientific rationales or technical sections using established templates
- Support responses to regulatory agency questions with guidance from senior staff
- Support electronic publishing and filing activities following established procedures
- Perform quality checks to ensure documents meet regulatory and company formatting requirements
- Provide tactical regulatory support to cross-functional teams
- Track deliverables and timelines; escalate risks or delays as identified
- Develop working knowledge of applicable regulatory requirements and systems
- Seek guidance appropriately and implement feedback into regulatory deliverables
- Support compliance activities, audits, and inspections through document preparation and record maintenance
- Assist in review of change controls and external communications for regulatory accuracy
- Support implementation of defined regulatory strategies through assigned deliverables
- Coordinate requests and information flow with internal teams and approved external partners
We could combine some but keep as separate li.
**Requirements**: Required: Associate’s degree – If no degree + 2 years relevant experience. Also maybe "Position requires excellent verbal and written communication skills in English." Could be skill but we can put under Requirements.
Also "ERP/MRP system (SAP preferred)" maybe skill.
But we have separate Skills section.
Let's decide: Requirements: education/experience.
Qualifications: maybe language preference (French Canadian, Spanish) and other preferred qualifications.
Skills: communication, interpersonal, organizational, collaborative, etc.
But we need to avoid duplication.
Let's parse required and preferred.
From text:
"Required: Associate’s degree – If no degree + 2 years relevant experience. Preferred: Other languages: French (Canadian) and/or Spanish (desired) Position requires excellent verbal and written communication skills in English. ERP/MRP system (SAP preferred) Interpersonal skills must include clear and concise verbal and written communication to others within facility. This is extended to external communication with government agencies, consultants, and contract clients as defined by Regulatory management. Position must be able to assist with resolution negotiations that impact Regulatory compliance by creating reasoned and rationale strategies to guide the organization. Must demonstrate a collaborative work style, with an ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational and communication skills."
So many of these are skills/competencies.
We could put under Skills: verbal/written communication, interpersonal, collaborative, organizational, ERP/MRP (SAP), language (French Canadian, Spanish), negotiation/resolution strategies.
But the instruction says we can have Skills section.
We also have Working Environment details: "Operates in a routine environment with simple rules and detailed instruction. Maintains disciplined, self-motivated remote work practices, ensures timely deliverables, and attends required web-based meetings. Manages conflict, influences outcomes, and escalates issues as appropriate. Develops an understanding of product and project issues and learns to identify relevant regulations and external guidance. Assists in problem-solving by providing input, drafting recommendations, and supporting proposed actions to address regulatory issues. Be able to lift 20 lbs. unassisted. Prolonged Sitting"
That could be part of Requirements or maybe a separate section like Working Conditions, but not in allowed headings. Could be included under Requirements or Skills? Might be better to include under Requirements as part of job requirements.
Location and shift: "Location: Spokane, WA — Remote, Full- -Time Shift: Weekday Days,M-F". This is schedule/location.
We have Pay: "Hiring Wage: $32.01 - $43.30, with opportunities for growth, promotion, and annual raises."
Benefits: list: Medical, Dental & Vision coverage; Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA); Life & AD&D Insurance; Short-Term & Long-Term Disability Insurance; Employee Assistance Program.
Also earlier "Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Dis
for prose. We need to include sections only when posting has real specific content. We need to avoid filler like "commensurate with experience", "not specified", etc. We need to output only HTML fragment. Let's extract content. The posting starts: "Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. For the Builders, Innovators, and Doers — This Is Your Place If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally. Why builders choose us: Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide. Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period. A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity. A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution. A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation. If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here." This is like an "About the role" or company overview. Could be "About the role" or maybe "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can put company overview under "About the role". Or maybe "About the role" is appropriate. Next: "Job Description: To provide foundational regulatory support to project teams by assisting with the preparation, maintenance, and submission of regulatory documentation while developing knowledge of regulatory requirements, guidance, and internal processes. The Associate role builds regulatory competency and reliability by executing defined tasks to ensure accuracy, compliance, and timely delivery of regulatory activities." Then bullet list of duties: "Regulatory Submissions (CMC) Assist with preparation, compilation, and filing of regulatory submissions (e.g., Amendments, Annual Reports, DMF updates) Gather and organize source documentation from SMEs to support submission readiness Draft routine scientific rationales or technical sections using established templates Support responses to regulatory agency questions with guidance from senior staff Operations / Systems Support electronic publishing and filing activities following established procedures Perform quality checks to ensure documents meet regulatory and company formatting requirements Project Support Provide tactical regulatory support to cross-functional teams Track deliverables and timelines; escalate risks or delays as identified Technical Guidance Develop working knowledge of applicable regulatory requirements and systems Seek guidance appropriately and implement feedback into regulatory deliverables Compliance Support compliance activities, audits, and inspections through document preparation and record maintenance Assist in review of change controls and external communications for regulatory accuracy Strategy Development Support implementation of defined regulatory strategies through assigned deliverables Interfacing Coordinate requests and information flow with internal teams and approved external partners" These are responsibilities/duties. Then "Required: Associate’s degree – If no degree + 2 years relevant experience. Preferred: Other languages: French (Canadian) and/or Spanish (desired) Position requires excellent verbal and written communication skills in English. ERP/MRP system (SAP preferred) Interpersonal skills must include clear and concise verbal and written communication to others within facility. This is extended to external communication with government agencies, consultants, and contract clients as defined by Regulatory management. Position must be able to assist with resolution negotiations that impact Regulatory compliance by creating reasoned and rationale strategies to guide the organization. Must demonstrate a collaborative work style, with an ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational and communication skills. Working Environment: Operates in a routine environment with simple rules and detailed instruction. Maintains disciplined, self-motivated remote work practices, ensures timely deliverables, and attends required web-based meetings. Manages conflict, influences outcomes, and escalates issues as appropriate. Develops an understanding of product and project issues and learns to identify relevant regulations and external guidance. Assists in problem-solving by providing input, drafting recommendations, and supporting proposed actions to address regulatory issues. Be able to lift 20 lbs. unassisted. Prolonged Sitting Location: Spokane, WA — Remote, Full- -Time Shift: Weekday Days,M-F" Then "Compensation & Benefits That Start on Day One — Because Your Well Being Matters Hiring Wage: $32.01 - $43.30, with opportunities for growth, promotion, and annual raises. At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success. Starting on your first day, you receive: Medical, Dental & Vision coverage Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D Insurance Short-Term & Long-Term Disability Insurance Employee Assistance Program" Then "Unlock Your Potential If you’re seeking a dynamic and rewarding career, we welcome your application today. Apply online: Careers - Jubilant HollisterStier Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require assistance applying for a position, contact: JHS-TalentAcquisition@jubl.com Our Promise: Caring, Sharing, Growing We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society." We need to remove EEO/AA, application instructions, contact, etc. Also remove duplicated lines. We need to keep substantive info: company overview, job description, responsibilities, required qualifications, preferred qualifications, working environment, location, shift, compensation, benefits. We need to decide sections. Possible sections: - About the role (company overview and why builders choose us) - Responsibilities (list of duties) - Requirements (required qualifications) - Qualifications (maybe preferred qualifications) - Skills (maybe communication, organizational, etc.) - Benefits (list) - Pay (hiring wage) - Schedule (location, shift, remote, full-time) We need to avoid filler like "Opportunities for growth, promotion, and annual raises" maybe belongs in Benefits or Pay? It's part of compensation description. We need to ensure we don't create sections with placeholder text. Let's extract each. **About the role**: The initial paragraph about company and why builders choose us. Could be combined. We'll produce a
with that prose. **Responsibilities**: The bullet list under Job Description and the enumerated duties. We'll make a
- for each duty. List them: - Assist with preparation, compilation, and filing of regulatory submissions (e.g., Amendments, Annual Reports, DMF updates) - Gather and organize source documentation from SMEs to support submission readiness - Draft routine scientific rationales or technical sections using established templates - Support responses to regulatory agency questions with guidance from senior staff - Support electronic publishing and filing activities following established procedures - Perform quality checks to ensure documents meet regulatory and company formatting requirements - Provide tactical regulatory support to cross-functional teams - Track deliverables and timelines; escalate risks or delays as identified - Develop working knowledge of applicable regulatory requirements and systems - Seek guidance appropriately and implement feedback into regulatory deliverables - Support compliance activities, audits, and inspections through document preparation and record maintenance - Assist in review of change controls and external communications for regulatory accuracy - Support implementation of defined regulatory strategies through assigned deliverables - Coordinate requests and information flow with internal teams and approved external partners We could combine some but keep as separate li. **Requirements**: Required: Associate’s degree – If no degree + 2 years relevant experience. Also maybe "Position requires excellent verbal and written communication skills in English." Could be skill but we can put under Requirements. Also "ERP/MRP system (SAP preferred)" maybe skill. But we have separate Skills section. Let's decide: Requirements: education/experience. Qualifications: maybe language preference (French Canadian, Spanish) and other preferred qualifications. Skills: communication, interpersonal, organizational, collaborative, etc. But we need to avoid duplication. Let's parse required and preferred. From text: "Required: Associate’s degree – If no degree + 2 years relevant experience. Preferred: Other languages: French (Canadian) and/or Spanish (desired) Position requires excellent verbal and written communication skills in English. ERP/MRP system (SAP preferred) Interpersonal skills must include clear and concise verbal and written communication to others within facility. This is extended to external communication with government agencies, consultants, and contract clients as defined by Regulatory management. Position must be able to assist with resolution negotiations that impact Regulatory compliance by creating reasoned and rationale strategies to guide the organization. Must demonstrate a collaborative work style, with an ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational and communication skills." So many of these are skills/competencies. We could put under Skills: verbal/written communication, interpersonal, collaborative, organizational, ERP/MRP (SAP), language (French Canadian, Spanish), negotiation/resolution strategies. But the instruction says we can have Skills section. We also have Working Environment details: "Operates in a routine environment with simple rules and detailed instruction. Maintains disciplined, self-motivated remote work practices, ensures timely deliverables, and attends required web-based meetings. Manages conflict, influences outcomes, and escalates issues as appropriate. Develops an understanding of product and project issues and learns to identify relevant regulations and external guidance. Assists in problem-solving by providing input, drafting recommendations, and supporting proposed actions to address regulatory issues. Be able to lift 20 lbs. unassisted. Prolonged Sitting" That could be part of Requirements or maybe a separate section like Working Conditions, but not in allowed headings. Could be included under Requirements or Skills? Might be better to include under Requirements as part of job requirements. Location and shift: "Location: Spokane, WA — Remote, Full- -Time Shift: Weekday Days,M-F". This is schedule/location. We have Pay: "Hiring Wage: $32.01 - $43.30, with opportunities for growth, promotion, and annual raises." Benefits: list: Medical, Dental & Vision coverage; Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA); Life & AD&D Insurance; Short-Term & Long-Term Disability Insurance; Employee Assistance Program. Also earlier "Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Dis