Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

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

📋 Description

• Assist in implementing global regulatory CMC strategies for both marketed and developmental products.

• Aid in the preparation and submission of regulatory CMC documentation for small molecules.

• Offer regulatory support and advice to various cross-functional teams.

• Review CMC sections of regulatory submissions, including interactions and responses with regulatory authorities.

• Participate in the formulation of global regulatory CMC strategies for commercial products.

• Collaborate with regulatory colleagues in developing global regulatory CMC strategies and submissions.

• Provide regulatory assessment and guidance on compliance issues related to products, including change controls, deviations, and GMP investigations.

⛳️ Requirements

• Excellent interpersonal skills to convey intricate information and guide others effectively.

• In-depth knowledge of regulatory guidelines (FDA, EMA, Health Canada, LATAM, Middle East, and ICH).

• Experience in the preparation and writing of CMC submissions.

• Strong strategic thinking capabilities and adept problem-solving skills.

• Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner.

• Strong organizational skills with a focus on planning and prioritization, capable of working with all management levels.

• Skilled in strategic thinking with the ability to navigate complex and ambiguous situations.

• Solid understanding of cGMP, FDA, EMA, and ICH regulations.

• Bachelor's degree preferred in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another relevant life-science discipline.

🏝️ Benefits

• We are dedicated to fostering the growth of our employees through career development and advancement opportunities.

• Supportive and engaged line management team.

• Comprehensive technical and therapeutic area training.

• Peer recognition and a total rewards program.

• Commitment to cultivating an inclusive culture.