PAREXEL has supported 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.
Post : Regulatory Affairs Consultant, Senior Regulatory Affairs Associate, Regulatory Affairs Associate
Regulatory Affairs, CMC- Biologics
Experience : 4 to 9 Years
Job Description
• 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 :
Date - 19th October, 2024
Venue - Bengaluru Office
Time - 10:00 AM onwards
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