Regulatory Affairs Associate Role

1 day ago

kolkata, India beBeeRegulatoryAffairspartner Full time

Regulatory Affairs ProfessionalWe are seeking an experienced Regulatory Affairs Professional to join our team. As a key member of our regulatory affairs group, you will be responsible for preparing and delivering regulatory submissions from a global and regional perspective.The ideal candidate will have 3+ years of experience handling new registrations, 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, and Australia.Key Responsibilities:Contribute to the preparation and delivery of regulatory submissions from a global and regional perspective.Prepare and review Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada, Switzerland, and Australia.Have a good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in ICH countries.A strong understanding of regulatory affairs principles, excellent communication and collaboration skills, and the ability to work independently are essential requirements for this role. If you are a motivated and detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this challenging opportunity that offers a competitive compensation package, comprehensive benefits, and opportunities for growth and development in a dynamic and innovative organization.This is an exciting opportunity to leverage your expertise and experience to drive business success and contribute to the development of a world-class regulatory affairs function that is recognized for its excellence and innovation.

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