At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Join us for a Walk-In Drive in Bengaluru for exciting CMC-Biologics roles! This drive is exclusively for experienced candidates only. Elevate your career with us—don’t miss out!
Job Description:
- Department: Regulatory Affairs,
- Division: CMC- Biologics
- Roles: Regulatory Affairs Consultant / Senior Regulatory Affairs Associate / Regulatory Affairs Associate
- Experience : 4 to 9 Years
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Key competencies:
- Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated(EU/US/Canada) and emerging markets.
- Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.
- Proficiency in Regulatory Information Management Systems like Veeva Vault Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications and collaboration skills ;
- Ability to work independently.
Walk in Drive Details :
- Date – 19th October, 2024
- Venue – Bengaluru Office
- Time – 10:00 AM onwards
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