Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics
Merck
4 months ago
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Associate Principal Scientist, Regulatory CMC - Biologics (R4)
Responsibilities:
- Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Prepare and submit CMC sections for commercial or new biologics products.
- Assist with development and implementation of internal regulatory strategies; provide mentoring and coaching to Sr. Scientist / Scientist.
- Participate in the authorization process to prioritize submissions.
- Complete detailed global regulatory assessments per established guidelines/policies and timelines.
- Develop and execute global regulatory strategies for submission/approval of INDs, BLAs, and/or post-approval change documentation.
- Plan, track, and communicate submission/approval status to support continued product supply.
- Lead authoring of clear, concise, effective IND/CTAs, BLAs, and/or global post-approval submissions per timelines.
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness.
- Resolve project issues via cross-team collaboration and escalation to CMC leadership as appropriate.
- Participate in early/late development programs and departmental/cross-functional efforts to improve CMC content/processes.
Education:
- B.S. in a science, engineering, or related field (advanced degree preferred). Related fields include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
- At least 10 years subject matter expertise in biologics CMC development or manufacturing, including prior biologics IND, BLA, and/or post-approval filing experience.
- Biologics regulatory CMC experience in both pre-approval and registration, including authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
- Strong understanding of related areas (e.g., manufacturing, process development, analytical, quality assurance) and ability to solve new/diverse problems creatively.
- Experience critically reviewing scientific information and evaluating whether arguments are clear and supported by data.
- Superior oral and written communication skills in multicultural settings; ability to communicate complex issues succinctly and logically.
- Flexibility to respond to changing priorities and unexpected events.
- Demonstrated leadership, project management, communication, interpersonal, and negotiating skills.
- Ability to generate innovative solutions to complex regulatory problems and work effectively with key stakeholders.
Preferred Experience and Skills:
- Experience with ADCs through commercialization.
- Preferred fields of study: Microbiology, Virology, Molecular Biology, Engineering, or Biochemistry.
Required Skills (as listed):
- Accountability, Adaptability, Cross-Cultural Awareness, Detail-Oriented; eCTD, Documentation; International Regulatory Compliance; Regulatory CMC/Compliance; Biologics License Application (BLA); Manufacturing; Regulatory Affairs Management; Employee Training Programs; plus related biochemistry/immunology/pharmaceutical process development skills.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Apply no later than the day before the posting end date (05/8/2026).
Responsibilities:
- Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Prepare and submit CMC sections for commercial or new biologics products.
- Assist with development and implementation of internal regulatory strategies; provide mentoring and coaching to Sr. Scientist / Scientist.
- Participate in the authorization process to prioritize submissions.
- Complete detailed global regulatory assessments per established guidelines/policies and timelines.
- Develop and execute global regulatory strategies for submission/approval of INDs, BLAs, and/or post-approval change documentation.
- Plan, track, and communicate submission/approval status to support continued product supply.
- Lead authoring of clear, concise, effective IND/CTAs, BLAs, and/or global post-approval submissions per timelines.
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness.
- Resolve project issues via cross-team collaboration and escalation to CMC leadership as appropriate.
- Participate in early/late development programs and departmental/cross-functional efforts to improve CMC content/processes.
Education:
- B.S. in a science, engineering, or related field (advanced degree preferred). Related fields include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
- At least 10 years subject matter expertise in biologics CMC development or manufacturing, including prior biologics IND, BLA, and/or post-approval filing experience.
- Biologics regulatory CMC experience in both pre-approval and registration, including authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
- Strong understanding of related areas (e.g., manufacturing, process development, analytical, quality assurance) and ability to solve new/diverse problems creatively.
- Experience critically reviewing scientific information and evaluating whether arguments are clear and supported by data.
- Superior oral and written communication skills in multicultural settings; ability to communicate complex issues succinctly and logically.
- Flexibility to respond to changing priorities and unexpected events.
- Demonstrated leadership, project management, communication, interpersonal, and negotiating skills.
- Ability to generate innovative solutions to complex regulatory problems and work effectively with key stakeholders.
Preferred Experience and Skills:
- Experience with ADCs through commercialization.
- Preferred fields of study: Microbiology, Virology, Molecular Biology, Engineering, or Biochemistry.
Required Skills (as listed):
- Accountability, Adaptability, Cross-Cultural Awareness, Detail-Oriented; eCTD, Documentation; International Regulatory Compliance; Regulatory CMC/Compliance; Biologics License Application (BLA); Manufacturing; Regulatory Affairs Management; Employee Training Programs; plus related biochemistry/immunology/pharmaceutical process development skills.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Apply no later than the day before the posting end date (05/8/2026).