Principal Scientist (Director) - Regulatory Affairs-CMC
Merck
4 months ago
Remote friendly (Rahway, NJ)
United States
Operations
Principal Scientist / Director, Global Regulatory CMC Biologics (R5)
Role Overview
- Develop and implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Lead preparation and submission of CMC sections for commercial and new biologics products.
- Develop and implement internal regulatory strategies and mentor/coach Sr. Scientists and Associate Principal Scientists.
Responsibilities
- Serve as Regulatory CMC Project Lead and provide CMC regulatory leadership within Regulatory and cross-functional teams for assigned biological products.
- Apply global CMC guidelines for IND/BLAs and post-approval changes.
- Deliver regulatory milestones for higher-complexity products, including assessment of probability of regulatory success and risk mitigation.
- Lead development, communication, and review of CMC Regulatory Strategy Documents for projects of increasing complexity.
- Lead development and execution of detailed, global regulatory submissions (INDs, BLAs, and post-approval change documentation) within defined timelines.
- Manage CMC documentation (IND/CTA, original BLA/MAA, or post-approval lifecycle), including agency background packages and responses to health authority questions.
- Collaborate on critical review of submissions to ensure compliance, scientific excellence, accuracy, and completeness.
- Resolve complex project issues with cross-functional partners and recommend actions to Regulatory CMC leadership as appropriate.
- Provide regulatory leadership for product in-license/due diligence reviews, divestment, and withdrawal.
- Support new technology development.
- Maintain a strong focus on compliance.
- May manage or mentor junior team members.
Technical Skills
- Critically review detailed scientific information and evaluate whether technical arguments are clear and conclusions are supported by data.
- Strong oral and written communication skills in multicultural settings; communicate complex issues succinctly and logically.
- Solid understanding of related fields (e.g., manufacturing, analytical, quality assurance) and creative problem-solving.
Leadership Skills
- Generate innovative solutions to complex regulatory problems and effectively partner with key stakeholders.
- Remain flexible with changing priorities and unexpected events.
- Effective leadership, communication, interpersonal, and negotiating skills with cross-functional partners and health authorities.
Education
- B.S. in a biological science, engineering, or related field (advanced degree preferred). Relevant fields include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry, or Biochemistry.
Required Experience and Skills
- At least 10 years of relevant experience in biologics/vaccine Regulatory CMC, development, manufacturing/testing/licensure of biological products, or closely related fields.
- Proficiency in English; additional languages are a plus.
- Periodic travel may be required.
Preferred Experience and Skills
- Regulatory CMC experience in ADCs.
Required/Notable Skills (as listed)
- Accountability, adaptability, audits/compliance, data integrity, change management, mentorship, regulatory affairs compliance/management, and related domain skills.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Role Overview
- Develop and implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Lead preparation and submission of CMC sections for commercial and new biologics products.
- Develop and implement internal regulatory strategies and mentor/coach Sr. Scientists and Associate Principal Scientists.
Responsibilities
- Serve as Regulatory CMC Project Lead and provide CMC regulatory leadership within Regulatory and cross-functional teams for assigned biological products.
- Apply global CMC guidelines for IND/BLAs and post-approval changes.
- Deliver regulatory milestones for higher-complexity products, including assessment of probability of regulatory success and risk mitigation.
- Lead development, communication, and review of CMC Regulatory Strategy Documents for projects of increasing complexity.
- Lead development and execution of detailed, global regulatory submissions (INDs, BLAs, and post-approval change documentation) within defined timelines.
- Manage CMC documentation (IND/CTA, original BLA/MAA, or post-approval lifecycle), including agency background packages and responses to health authority questions.
- Collaborate on critical review of submissions to ensure compliance, scientific excellence, accuracy, and completeness.
- Resolve complex project issues with cross-functional partners and recommend actions to Regulatory CMC leadership as appropriate.
- Provide regulatory leadership for product in-license/due diligence reviews, divestment, and withdrawal.
- Support new technology development.
- Maintain a strong focus on compliance.
- May manage or mentor junior team members.
Technical Skills
- Critically review detailed scientific information and evaluate whether technical arguments are clear and conclusions are supported by data.
- Strong oral and written communication skills in multicultural settings; communicate complex issues succinctly and logically.
- Solid understanding of related fields (e.g., manufacturing, analytical, quality assurance) and creative problem-solving.
Leadership Skills
- Generate innovative solutions to complex regulatory problems and effectively partner with key stakeholders.
- Remain flexible with changing priorities and unexpected events.
- Effective leadership, communication, interpersonal, and negotiating skills with cross-functional partners and health authorities.
Education
- B.S. in a biological science, engineering, or related field (advanced degree preferred). Relevant fields include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry, or Biochemistry.
Required Experience and Skills
- At least 10 years of relevant experience in biologics/vaccine Regulatory CMC, development, manufacturing/testing/licensure of biological products, or closely related fields.
- Proficiency in English; additional languages are a plus.
- Periodic travel may be required.
Preferred Experience and Skills
- Regulatory CMC experience in ADCs.
Required/Notable Skills (as listed)
- Accountability, adaptability, audits/compliance, data integrity, change management, mentorship, regulatory affairs compliance/management, and related domain skills.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.