Senior Regulatory Affairs Consultant- CMC Biologics

Senior Regulatory Affairs Consultant- CMC Biologics

• Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma‑derived therapies across major markets such as the US, EU, Japan, Canada, Switzerland, and Australia.
• Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
• Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
• Strong communication and collaboration skills, ability to work independently.
• The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets.

10 to 14 years of relevant experience

India Remote

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.