The Senior Regulatory Affairs Associate will handle new registrations, life cycle management, and regulatory submissions for various biological products globally, requiring strong collaboration skills and regulatory knowledge.
When our values align, there's no limit to what we can achieve.
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.
Senior Regulatory Affairs Associate
- Good experience in handling of new registration, 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, Australia.
- Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
- Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
- 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 the ICH countries.
- Strong communication and collaboration skills, ability to work independently.
Top Skills
Biologicals
Monoclonal Antibodies
Plasma Derived And Small Molecules
Recombinant Protein Molecules
Vaccines
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