Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Implement the commercial Lifecycle Management (LCM) strategy and submissions with an emphasis on US, Canada, and EU markets.

• Analyze the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions, as well as interactions and responses with regulatory bodies.

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

• Actively participate in cross-functional teams.

• Function as the main regulatory CMC contact for designated products and projects.

⛳️ Requirements

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

• Generally requires 4 years of experience in the pharmaceutical sector or a related field, or an equivalent combination of education and experience.

• Experience supporting Small Molecule programs is preferred.

• Experience with Veeva RIM is essential.

• Familiarity with FDA, EMA, Health Canada, and ICH regulatory guidelines is a must.

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

• Excellent interpersonal, problem-solving, collaboration, communication, planning, and prioritization skills.

• Capability to engage with all levels of management.

🏝️ Benefits

• Opportunities for career advancement and development.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Provision of a company car or car allowance.

• Medical, dental, and vision insurance benefits.

• 401(k) plan with company match.

• Eligibility to join the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave policies.