Senior Regulatory Affairs Consultant, CMC Biologics
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Job Description
Senior Regulatory Affairs Consultant at Parexel overseeing global regulatory submissions for biological products. Collaborating on project planning and execution in a team environment to meet client expectations.
Responsibilities:
- Contribute to preparation and delivery of regulatory submissions
- Preparation and review of Marketing Authorization Applications & Variations
- Responsible for project planning and set-up
- Ensures client expectations for quality and timeliness are met
- Identifies new opportunities through Change in Scope or add-on business
- Produces quality work that meets expectations of PC and the client
- Supports development of business solutions addressing specific client needs
Requirements:
- 10+ 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
- Good understanding of regulatory framework
- Strong communication and collaboration skills
- Ability to work independently
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree preferred
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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