Regulatory Affairs Consultant
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Job Description
Regulatory Affairs Consultant ensuring compliance in clinical development processes at Parexel. Managing and preparing regulatory submissions for various markets including US, EU, and Japan.
Responsibilities:
- 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.
Requirements:
- 6+ years of 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
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions
- Strong communication and collaboration skills, ability to work independently.
Benefits:
- Health insurance
- Professional development opportunities
- Flexible work arrangements
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