SM/AD Regulatory Affairs CMC – Small Molecule

Sr. Manager/ Associate Director Regulatory CMC – Small Molecule

Want to join a Global Pharmaceutical leader?
This client is a Global Bio-pharmaceutical Company focused on delivering high quality treatments to patients. They have a robust pipeline of development products and 9 commercial stage assets.

Responsibilities:

• Provide regulatory strategic and/or operational support for Small-Molecule products.
• Provide regulatory CMC leadership on the cross functional teams and advise on best practices and/or supports Commercial Teams, as assigned by the Regulatory CMC Leadership Team.
• Lead/Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions
• Ensure effective communication of CMC regulatory strategy, risks, and overall plans to GRA Teams, S&TS Teams and Development and Commercial Teams.
• Lead or provide input to internal regulatory business initiatives and/or cross functional work streams

Qualifications:

• Bachelor’s degree in a scientific discipline required, advanced degree preferred
• 4-5 years of regulatory affairs CMC experience in clinical phase submissions and health authority interactions, marketing authorization application experience preferred
• Small molecule development or manufacturing experience required. NDA experience highly preffered.
• Experience and knowledge in preparation of initial INDs/IMPD and amendments
• Experience in health authority interactions and addressing health authority questions
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
• Strong collaboration and cross-functional team participation skills
• Ability to prioritize and manage multiple tasks while delivering on respective timelines for each