Principal Scientist; Director - Regulatory Affairs-CMC

Job Description

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

Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr.

Scientist and Assoc Principal scientist in support of their assigned projects.

The Principal Scientist / Director responsibilities include but are not limited to:

• Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products.
• In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post approval changes.
• The CMC Project Lead is accountable for the delivery of all regulatory milestones for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
• Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation according to defined timelines.
• Manage execution of CMC documentation including IND/CTA, original BLA/MAA, or Post Approval Life Cycle, including agency background packages and response to health authority questions per established business processes and systems.
• Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory CMC leadership team as appropriate.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Support new technology development.
• Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval or continued market supply of biologics products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• May need to manage or mentor junior team members.

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities.

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.

• At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
• The candidate must be proficient in English; additional language skills are a plus.
• The candidate may be required to travel on a periodic basis.

• Regulatory CMC experience in ADCs

• Accountability
• Adaptability
• Audits Compliance
• Biological Engineering
• Biological Sciences
• Business Processes
• Change Management
• Chemical Engineering
• Confidentiality
• Cross-Cultural Awareness
• Data Integrity
• Decision Making
• Documentations
• Employee Training Programs
• Immunochemistry
• Life Cycle Support
• Mentorship
• Microbiology
• Molecular Biology
• Molecular Microbiology
• Pharmaceutical Process Development
• Project Tasks
• Regulatory Affairs Compliance
• Regulatory Affairs Management

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