Regulatory Associate
Description
The Regulatory Associate will exemplify excellent technical writing skills and develop productive working relationships with Manufacturing, Quality, Engineering, and client teams. The Associate will demonstrate exceptional attention to detail and the ability to synthesize complex technical information into regulatory documents that meet FDA, EMA, JP, and other global regulatory authority expectations. The Associate will thrive in a collaborative environment while maintaining strong organizational skills and the ability to manage multiple client projects across various development phases and respond effectively to regulatory queries and information requests.
Working closely with the client regulatory affairs teams and cross-functional partners, the Regulatory Associate will be instrumental in developing high-quality Module 3 and appendixes sections for INDs, BLAs, and NDAs, supporting both clinical and commercial drug product manufacturing submissions. The Associate will need to successfully translate complex manufacturing processes, quality systems, and facility capabilities into clear, compliant regulatory narratives that support successful regulatory approvals from Phase I through commercial launch.
Essential Job Functions:
• Author Module 2.3.P Drug Product sections for INDs, BLAs, and NDAs supporting both clinical and commercial manufacturing, including formulation development, manufacture, control of drug product, reference standards, container closure systems, and stability studies.
• Develop comprehensive facility descriptions (Module 2.3.S.2.1 and 2.3.P.3.1) detailing manufacturing processes, equipment, utilities, environmental controls, and quality systems for both clinical and commercial sterile injectable manufacturing.
• Author regulatory appendix sections including facility master files, equipment lists, utility summaries, environmental monitoring programs, and cleaning validation summaries.
• Track regulatory intelligence on evolving guidance documents related to drug product manufacturing, facility requirements, and query response expectations.
• Support regulatory inspections by preparing facility-related documentation and participating in inspector presentations for both clinical and commercial operations.
• Maintain project timelines and communicate status updates to internal teams and clients regarding submission milestones and query response deadlines.
• Support post-approval regulatory activities including annual reports, comparability assessments, manufacturing supplement preparations, and lifecycle management documentation.
• Author and respond to regulatory queries from FDA, EMA, and other global regulatory authorities, providing comprehensive technical responses with supporting data and documentation.
• Prepare Annual Product Quality Reviews (APQRs) for commercial products, including trend analysis, quality metrics assessment, and continuous improvement recommendations.
• Support IND submissions for Phase I-III clinical trials, ensuring manufacturing and facility information meets regulatory expectations for clinical supply manufacturing.
• Collaborate with Manufacturing and Engineering teams to accurately capture facility capabilities, equipment specifications, and process technologies across clinical and commercial operations.
• Work closely with Quality Assurance to document quality systems, GMP compliance programs, and quality control testing strategies for both clinical and commercial manufacturing.
• Coordinate with clients to gather product-specific information, review draft sections, and incorporate feedback into submissions across all development phases.
• Ensure compliance with ICH guidelines (M4, Q8, Q9, Q10, Q11) and regional regulatory requirements for Module 2 content and formatting for both clinical and commercial submissions.
• Maintain regulatory submission templates and standard language libraries for efficient document development across clinical and commercial products and multiple clients.
• Participate in regulatory strategy discussions to determine optimal approaches for presenting manufacturing and facility information throughout product lifecycle.
Special Job Requirements:
· Bachelor’s Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
· Minimum of 3 years of regulatory affairs experience in pharmaceutical industry with specific experience in IND, BLA, and NDA preparation supporting both clinical and commercial manufacturing.
· Proven experience authoring Module 3 sections for drug products, particularly Section 2.3.P, facility-related content, and regulatory appendices.
· Demonstrated experience authoring regulatory query responses with ability to provide comprehensive technical responses to FDA, EMA, and other regulatory authorities.
· Experience preparing Annual Product Quality Reviews (APQRs) or similar post-market surveillance reports with trend analysis and quality assessment.
· Strong knowledge of ICH guidelines including M4 (Common Technical Document), Q8-Q12 quality guidelines, and regional regulatory requirements for clinical and commercial submissions.
· Experience with sterile injectable manufacturing for both clinical and commercial production, including understanding of aseptic processing, terminal sterilization, and parenteral drug product requirements.
· Excellent technical writing skills with ability to create clear, concise, and scientifically accurate regulatory documents and query responses.
· Strong project management skills with ability to handle multiple client projects across different development phases and meet tight submission and query response deadlines.
· Knowledge of cGMP requirements for pharmaceutical manufacturing and quality systems in both clinical and commercial environments.
· Experience working in CDMO environment preferred, with understanding of client service expectations and multi-product manufacturing considerations across development phases.
Additional Preferences:
· Knowledge of global regulatory requirements beyond FDA including EMA, Health Canada, and other major markets for clinical and commercial submissions.
· Experience with regulatory inspections and FDA/EMA pre-approval facility assessments for both clinical and commercial operations.
· Proven track record of successful query resolution with regulatory authorities, including complex technical queries and facility-related information requests.
· Experience with Annual Product Quality Review preparation including statistical analysis, trend identification, and continuous improvement planning.
· Experience with post-approval regulatory activities including manufacturing supplements, annual reports, and lifecycle management for commercial products.
· Strong understanding of pharmaceutical development from preclinical through commercial manufacturing with experience supporting product lifecycle transitions.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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