Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM

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

📋 Description

• Assist in the implementation of 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 guidance to various cross-functional teams to ensure all relevant global regulatory requirements are adequately considered and integrated into development and commercial initiatives.

• Review CMC sections of regulatory submissions, along with interactions and responses with regulatory bodies.

• Contribute to the formulation of global regulatory CMC strategies for commercial products.

• Collaborate with regulatory colleagues in the development of global regulatory CMC strategies and submissions.

• Provide regulatory CMC guidance to cross-functional teams and key stakeholders.

• Support regulatory assessments and guidance on product compliance issues, including change controls, deviations, and GMP investigations.

⛳️ Requirements

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

• Proficient in regulatory guidelines (FDA, EMA, Health Canada, LATAM, Middle East, and ICH).

• Experience in the preparation and writing of CMC submissions.

• Strategic thinker with strong problem-solving abilities.

• Capable of collaborating and communicating in an open, clear, complete, timely, and consistent manner.

• Strong planning and prioritization skills, with the ability to work effectively with all management levels.

• Able to think strategically and resolve complex and ambiguous situations.

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

• Bachelor's degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life sciences field.

🏝️ Benefits

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

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a comprehensive total rewards program.

• Committed to fostering an inclusive culture.