Principal Scientist (Director) - Regulatory Affairs-CMC

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)

Responsibilities:
- 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 or new biologics products.
- Serve as Regulatory CMC Project Lead and provide CMC regulatory leadership within Regulatory and cross-functional teams for assigned products.
- Apply global CMC guidelines for IND/BLAs and post-approval changes.
- Deliver regulatory milestones for higher-complexity products, including assessment of regulatory success probability and risk-mitigation measures.
- Lead development, communication, and review of the CMC Regulatory Strategy Document.
- Lead global development and execution of regulatory submissions (INDs, BLAs, and post-approval change documentation) within defined timelines.
- Manage CMC documentation execution for IND/CTA, original BLA/MAA, or Post Approval Life Cycle, including agency background packages and responses to health authority questions.
- Collaborate with partners to ensure submissions are compliant, scientifically excellent, and accurate/complete.
- Resolve complex project issues with cross-functional partners and provide recommendations to Regulatory CMC leadership.
- Provide regulatory leadership for product in-license/due diligence review, divestment, and withdrawal.
- Support new technology development.
- Maintain unwavering focus on compliance.
- May manage or mentor junior team members.

Technical Skills:
- Critically review scientific information; assess clarity of arguments and whether conclusions are supported by data.
- Strong oral and written communication in multicultural settings; ability to communicate complex issues succinctly and logically.
- Sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and creative problem-solving.

Leadership Skills:
- Generate innovative solutions to complex regulatory problems and collaborate 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 biological science, engineering, or related field (advanced degree preferred).

Required Experience/Skills:
- At least 10 years of relevant experience in biologics/vaccine Regulatory CMC or development; manufacturing/testing/licensure of biological products; or closely related fields.
- Proficient in English.
- Periodic travel may be required.

Preferred Experience/Skills:
- Regulatory CMC experience in ADCs.

Required Skills (from posting):
- Accountability, adaptability, compliance/audits, cross-cultural awareness, data integrity, decision making, mentorship, and related regulatory/biological engineering documentation/support competencies.

Application Instructions:
- Apply via https://jobs.merck.com/us/en (application deadline stated on the posting).