Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics

Associate Principal Scientist, Regulatory CMC - Biologics (R4) (equivalent to an Associate Director)

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 in development and implementation of internal regulatory strategies.
- Mentor and coach Sr. Scientist/Scientist on assigned projects.
- Participate in the authorization process to prioritize submissions.
- Complete detailed global regulatory assessments per established guidelines/policies and defined timelines.
- Develop and execute global regulatory strategies for submission and 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 IND/CTA, BLA, and global post-approval submissions per timelines.
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions.
- Resolve project issues through team collaboration and escalate to CMC leadership as appropriate.
- Participate in early/late development programs and cross-functional efforts to improve CMC content or processes as needed.

Education Minimum Requirement:
- B.S. in a science, engineering, or related field (advanced degree preferred). 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; prior biologics IND, BLA, and/or post-approval filing experience.
- Experience in biologics regulatory CMC in both pre-approval and registration, including authoring agency interactions/responses and IND/IMPD and BLA sections.
- Sound understanding of related fields (manufacturing, process development, analytical, quality assurance); ability to solve new/diverse problems.
- Proven ability to critically review scientific information and evaluate whether arguments and conclusions are supported by data.
- Superior oral and written communication skills in multicultural settings; concise, logical communication of complex issues.
- Flexibility with changing priorities/unexpected events.
- Effective leadership, project management, interpersonal/negotiating, and communication 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, Detail-Oriented, Cross-Cultural Awareness
- Biochemistry/Biological Sciences
- Biologics License Application (BLA)
- Chemical Engineering/Chemical Technology
- Documentations; Electronic Common Technical Document (eCTD)
- Immunochemistry/Immunology
- International Regulatory Compliance
- Manufacturing; Microbiology; Molecular Biology; Molecular Microbiology
- Pharmaceutical Process Development; Project Tasks
- Regulatory Affairs Management; Regulatory CMC; Regulatory Compliance

Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.