Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM

This is a fully remote position, open to applicants in Argentina, +4 more countries.

📋 Description

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

• Aid in the creation and submission of regulatory CMC documentation pertaining to small molecules.

• Evaluate CMC sections within regulatory submissions, including interactions and responses with regulatory authorities.

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

• Collaborate with regulatory colleagues to formulate global regulatory CMC strategies and submissions.

• Offer regulatory CMC advice to cross-functional teams and key stakeholders.

• Assist in regulatory assessments and provide guidance on compliance matters, including change controls, deviations, and GMP investigations.

⛳️ Requirements

• Excellent interpersonal skills for effectively conveying complex information and providing guidance.

• Expertise in regulatory guidelines from FDA, EMA, Health Canada, LATAM, Middle East, and ICH.

• Experience in preparing and authoring CMC submissions.

• Strategic thinker with strong problem-solving capabilities.

• Competence in collaborative and clear communication in an open, timely, and consistent manner.

• Strong abilities in planning and prioritization.

• Capacity to engage with all levels of management.

• Proficiency in resolving 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 a related life-science discipline.

• Equivalent experience, skills, and/or education may also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive company culture.

• Reasonable accommodations available when appropriate under the Americans with Disabilities Act.