PAREXEL has announced recruitment for Regulatory Affairs Consultant and Senior Regulatory Affairs Associate positions. PAREXEL supports the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Job Overview
PAREXEL is recruiting for the posts of Regulatory Affairs Consultant and Senior Regulatory Affairs Associate in Bengaluru and Hyderabad within the Pharma/ Healthcare/ Clinical research industry and Regulatory Affairs functional area.
Important Dates
- End Date: 20th April 2026
Eligibility Criteria
Regulatory Affairs Consultant
Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (Biologicals, Vaccines) in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia. Key competencies include experience in authoring, compiling and submission of country specific submissions (MAA, BLA, and post approval changes) of Biologics/Biosimilar products; good understanding of regulatory guidelines and framework; proficiency in Regulatory Information Management Systems like Veeva Vault; experience handling CMC related health authority queries; preparation/review of regulatory gap analysis and strategy documents; and authoring/review of CMC component of Marketing Authorization Applications, Variations, and Annual Reports. Strong communications skills and ability to guide and mentor team members, and ability to work independently are required.
Senior Regulatory Affairs Associate
5 to 8 years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia. Candidates should contribute to preparation and delivery of regulatory submissions; preparation and review of Marketing Authorization Applications & Variations for filing in specified markets; have a good understanding of regulatory framework and global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Strong communication and collaboration skills, and ability to work independently are required.
How to Apply
Interested and eligible candidates can apply online for these positions through the official application links provided below.
Official Notification & Links
- Regulatory Affairs Consultant: Apply here
- Senior Regulatory Affairs Associate: Apply here
Conclusion
Eligible candidates with the required experience in Regulatory Affairs may consider applying for these opportunities at PAREXEL before the specified end date.
