Principal Scientist (Director) - Regulatory Affairs-CMC
Merck, Rahway, NJ, United States
Overview
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, leading the development and implementation of internal regulatory strategies, and providing mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects.
Responsibilities
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.
Apply in-depth knowledge of global CMC guidelines regarding IND/BLAs or post-approval changes.
Deliver all regulatory milestones for higher complexity products, including assessment of regulatory success probability 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 responses to health authority questions per established processes.
Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness.
Resolve complex project issues through collaboration with the team and cross-functional partners and provide recommendations to Regulatory CMC leadership 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 apply this understanding to ensure approval or continued market supply of biologics products worldwide.
Conduct all activities with an unwavering focus on compliance.
May mentor junior team members.
Technical Skills
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are clearly presented and supported by data.
Strong oral and written communication skills in multicultural settings and ability to communicate complex issues succinctly; strong listening skills.
Sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) with ability to be creative in solving problems.
Leadership Skills
Ability to generate innovative solutions to complex regulatory problems and effectively communicate with key stakeholders.
Flexibility in responding to changing priorities or unexpected events.
Effective leadership, communication, interpersonal and negotiating skills with cross-functional partners and health authorities.
Education Minimum Requirement
B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.
Required Experience And Skills
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.
Proficiency in English; additional language skills are a plus.
Periodic travel may be required.
Preferred Experience And Skills
Regulatory CMC experience in ADCs.
Notes EEO statements and related compliance information may be required by law; the employer is an Equal Employment Opportunity Employer and complies with applicable affirmative action requirements for protected veterans and individuals with disabilities.
Requisition ID: R386607
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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, leading the development and implementation of internal regulatory strategies, and providing mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects.
Responsibilities
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.
Apply in-depth knowledge of global CMC guidelines regarding IND/BLAs or post-approval changes.
Deliver all regulatory milestones for higher complexity products, including assessment of regulatory success probability 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 responses to health authority questions per established processes.
Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness.
Resolve complex project issues through collaboration with the team and cross-functional partners and provide recommendations to Regulatory CMC leadership 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 apply this understanding to ensure approval or continued market supply of biologics products worldwide.
Conduct all activities with an unwavering focus on compliance.
May mentor junior team members.
Technical Skills
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are clearly presented and supported by data.
Strong oral and written communication skills in multicultural settings and ability to communicate complex issues succinctly; strong listening skills.
Sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) with ability to be creative in solving problems.
Leadership Skills
Ability to generate innovative solutions to complex regulatory problems and effectively communicate with key stakeholders.
Flexibility in responding to changing priorities or unexpected events.
Effective leadership, communication, interpersonal and negotiating skills with cross-functional partners and health authorities.
Education Minimum Requirement
B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.
Required Experience And Skills
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.
Proficiency in English; additional language skills are a plus.
Periodic travel may be required.
Preferred Experience And Skills
Regulatory CMC experience in ADCs.
Notes EEO statements and related compliance information may be required by law; the employer is an Equal Employment Opportunity Employer and complies with applicable affirmative action requirements for protected veterans and individuals with disabilities.
Requisition ID: R386607
#J-18808-Ljbffr