Senior Manager CMC Regulatory Affairs

Senior Manager/ Associate Director CMC (Remote)

Company Background

• A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
• Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
• Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
• Clients include national and multinational pharmaceutical companies

About the Role

My Client is seeking an exceptional science professional to join their Regulatory Affairs team. The candidate will be responsible for supporting Biotechnology/Pharmaceutical clients throughout the regulatory filing process, including serving as the client lead as Senior Manager of Regulatory Affairs. A successful candidate will have a proven track record of learning and applying scientific principles to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.

Required Experience

• MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a related field.
• Around 7 years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD
• Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).
• Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
• Strategize regulatory CMC pathway for new small & large molecules
• Assess and strategize post-approval changes and relevant submission
• Authoring CMC amendments, supplements, and annual reports
• Preparing briefing documents for the health authority meetings
• Regulatory agency meeting support including meeting preparation and briefing document creation.
• Review of analytical test methods, specifications, and stability protocol/report/data
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product
• Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
• Sponsor consultancy regarding drug development including timeline management

What They’re Looking For

• Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
• Strong knowledge and demonstrated practice of cGMP.
• Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
• Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
• Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.