Associate Principal Scientist, Regulatory Affairs-CMC

Merck • North Wales, PA

1d • Hybrid

About The Position

Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC, this role is responsible for developing and implementing CMC regulatory strategies for the company's pharmaceutical pipeline products in accordance with global regulations and guidance. The role is also responsible for the preparation and submission of CMC dossiers for all assigned development products. Primary responsibilities include serving as a CMC Product Lead, leading the development and execution of global product and project regulatory strategy(ies), managing the execution of CMC documentation, and demonstrating an understanding of regulatory affairs to ensure the approval and launch market supply of pharmaceutical products worldwide. All activities must be conducted with an unwavering focus on compliance.

Requirements

• Bachelor's degree in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry.
• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• Proficient in English; additional language skills are a plus.

Nice To Haves

• Experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills.
• Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Ability to develop innovative and imaginative approaches to problem solving.
• Ability to flexibly respond to changing priorities or unexpected events.
• Superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities.
• Ability to work well under pressure.
• Excellent interpersonal, verbal and written communication, presentation, and listening skills.
• Proven record of working with, and influencing, multi-disciplinary teams.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Additional language skills are a plus.

Responsibilities

• Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.
• Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed.
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our Company's pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees