Senior Regulatory Affairs Consultant

Responsibilities

• Manage new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma-derived therapies.
• Contribute to the preparation and delivery of regulatory submissions from both global and regional perspectives.
• Prepare and review Marketing Authorization Applications and Variations for filing in major markets including the US, EU, Japan, Canada, Switzerland, and Australia.
• Apply deep knowledge of global pharmaceutical legislation and guidance, specifically regarding regulatory CMC aspects in ICH countries.
• Act as a team lead to guide and mentor team members on technical aspects of regulatory filings to global markets.

Requirements

• 10 to 14 years of relevant experience in regulatory affairs.
• Bachelor's degree in a Scientific or Technical Discipline (Advanced Degree preferred).
• Extensive experience with biological product registrations.
• Strong understanding of regulatory frameworks and regional trends for small and large molecules.
• Proven ability to work independently with strong communication and collaboration skills.

Benefits

• Flexible remote work arrangements.
• Opportunities for career growth through challenging assignments and diverse therapeutic area exposure.
• Mentorship from highly experienced regulatory professionals.
• A supportive, inclusive, and collaborative team environment.

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We are driven by a patient-centric mission, combining scientific expertise with empathy to bring life-changing products to market faster.