- Regulatory Affairs Consultant
- Senior Regulatory Affairs Associate
- Regulatory Affairs Associate
Positions Available:
- Regulatory Affairs Consultant
- Senior Regulatory Affairs Associate
- Regulatory Affairs Associate
Experience Required: 4 to 9 Years
Company Overview:
PAREXEL is a leading global biopharmaceutical service provider, supporting the Bio-Tech and Pharmaceutical industries in developing new drugs and treatments worldwide. We offer knowledge-based contract research, medical communications, and consulting services across various therapeutic areas.
Job Description:
Candidates should possess experience and expertise in the following areas:
- Authoring, compiling, and submitting country-specific submissions (MAA, BLA, and post-approval changes) for Biologics/Biosimilars in regulated (EU/US/Canada) and emerging markets.
- Contributing to the preparation and delivery of regulatory maintenance submissions, with an increasing complexity based on experience.
- Strong understanding of regulatory guidelines and frameworks, including regional trends.
- Proficiency in Regulatory Information Management Systems, such as Veeva Vault.
- Executing and maintaining submission delivery plans and content plans, with proactive updates to stakeholders.
- Excellent communication and collaboration skills, with the ability to work independently.
Walk-in Drive Details:
- Date: 19th October 2024
- Venue: Bengaluru Office
- Time: 10:00 AM onwards
If you are passionate about regulatory affairs and meet the qualifications, we encourage you to join us for this opportunity!
