Senior Regulatory Affairs Associate
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Job Description
Senior Regulatory Affairs Associate at Parexel managing regulatory submissions for Biologicals and vaccines. Involves global collaboration and understanding of regulatory frameworks across markets.
Responsibilities:
- Handle new registration and life cycle management of products
- Prepare and review Marketing Authorization Applications & Variations
- Collaborate on regulatory submissions from a global perspective
Requirements:
- Good experience in handling new registration and renewals of Biologicals, Vaccines, and small molecules
- Contribute to preparation and delivery of regulatory submissions
- Good understanding of regulatory framework for various types of applications
- Strong communication and collaboration skills
- Ability to work independently
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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