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Parexel Walk-In Drive in Bengaluru for exciting CMC-Biologics roles! Regulatory Affairs
Join us for a Walk-In Drive in Bengaluru for exciting CMC-Biologics roles! This drive is exclusively for experienced candidates only.
Regulatory Affairs, CMC- Biologics
Walk in Drive :
Date 19th October, 2024
Venue – Bengaluru Office
Time 10:00 AM onwards
Open roles:
Regulatory Affairs Consultant
Senior Regulatory Affairs Associate
> Regulatory Affairs Associate
Experience: 4 to 9 Years
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.
