Director, Regulatory CMC

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Develop and spearhead global CMC regulatory strategies for both investigational and commercial products.

• Prepare, review, and submit CMC sections of INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to the FDA, EMA, and other regulatory bodies.

• Provide regulatory advice on manufacturing modifications, process development, and technology transfers.

• Monitor and interpret existing and emerging CMC regulatory requirements, guidelines, and trends.

• Represent Regulatory CMC in cross-functional teams and meetings.

• Lead communications and interactions with regulatory agencies concerning CMC matters.

• Utilize influence and project management capabilities to promote alignment with organizational objectives.

• Collaborate with internal departments such as Quality, CMC, R&D, Finance, Legal, and Clinical.

• Partner with CROs and consultants to ensure regulatory compliance and preparedness.

⛳️ Requirements

• A bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related discipline is required.

• At least 10+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical sector.

• Experience in small molecule development, specifically in oncology.

• Demonstrated success in CMC submissions and approvals both in the US and internationally.

• Comprehensive knowledge of FDA, EMA, and ICH guidelines, regulations, and processes pertaining to CMC.

• Strong leadership, communication, and project management skills.

• Ability to work collaboratively in accordance with the company's stated values.

• Capable of thriving in a collaborative, fast-paced environment.

🏝️ Benefits

• Competitive compensation package.

• Equity participation opportunities.

• Exceptional benefits offered.

• Fully remote work environment.

• Flexible, results-oriented culture.