Director, CMC Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and execute global CMC regulatory strategies for biologic and combination products.

• Prepare and oversee CMC submissions, briefing documents, and health authority meeting packages, including INDs, CTAs, BLAs, MAAs, and post-approval filings.

• Act as the CMC Regulatory lead within cross-functional project teams.

• Assist with health authority interactions and provide responses to regulatory inquiries.

• Offer regulatory guidance on manufacturing, analytical, quality, and lifecycle matters.

• Evaluate the regulatory implications of manufacturing and lifecycle modifications and establish risk mitigation strategies.

• Partner with internal teams and external collaborators to facilitate development and commercialization.

• Keep updated on regulatory trends, guidance documents, and alterations to global regulatory requirements that impact CMC.

• Aid in product release, investigations, inspections, and pertinent SOP reviews.

⛳️ Requirements

• A Bachelor’s degree in a scientific field, such as Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline.

• At least 10 years of experience in Regulatory Affairs, CMC, or related roles within the pharmaceutical or biotechnology sectors, with substantial biologics expertise.

• Demonstrated experience in developing and implementing global CMC regulatory strategies for biologics throughout clinical and commercial phases.

• In-depth knowledge of global CMC regulatory requirements and experience with INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval submissions.

• Strong comprehension of biologics and combination product development and manufacturing, encompassing analytical methods, process validation, comparability, specifications, and stability.

• Experience in supporting health authority interactions, including regulatory meetings and addressing agency inquiries.

• Capability to evaluate the regulatory impacts of product, process, manufacturing, and lifecycle changes and formulate suitable regulatory strategies.

• Excellent leadership, project management, communication, and cross-functional collaboration abilities.

• Experience with biologics and combination products, including prefilled syringes and autoinjectors, is preferred.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development