Senior Regulatory Affairs Consultant

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

📋 Description

• Support the development and submission of regulatory documents from both global and regional perspectives.

• Prepare and review Marketing Authorization Applications & Variations for submission in the US, EU, Japan, Canada, Switzerland, and Australia.

• Provide guidance and mentorship to team members on technical matters, including regulatory filings for global markets.

⛳️ Requirements

• 10 to 14 years of relevant experience in the field.

• A minimum of a bachelor’s degree in a Scientific or Technical Discipline.

• Significant experience in managing new registrations, life cycle maintenance, and renewals for biological products.

• Strong understanding of the regulatory framework, including regional trends, for various types of applications and procedures for both small and large molecules.

• Excellent communication and collaboration abilities.

• Capability to work independently.

🏝️ Benefits

• Flexible work arrangements.