Regulatory Affairs Specialist
3 weeks ago
Regeneron is seeking a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our products with global regulatory requirements.
Key Responsibilities:- Regulatory Assessment and Compliance: Conduct thorough assessments of changes to ensure compliance with global regulatory requirements, including CMC and GMP regulations.
- Submission Strategies: Collaborate with cross-functional teams to develop and implement submission strategies that meet regulatory requirements and support clinical supply.
- Regulatory Release and QP Certification: Support the preparation and submission of regulatory release packages and QP certification processes.
- Communication and Stakeholder Management: Foster strong relationships with internal and external stakeholders, including IOPS and Global Development teams, to ensure effective communication and collaboration.
- Project Management: Work closely with management and stakeholders to ensure timely completion of projects and effective tracking of regulatory submission packages and approval status.
- Education: Bachelor's degree in a relevant technical or scientific discipline.
- Experience: Minimum 4+ years of pharmaceutical/biotech industry experience, including 3+ years of relevant CMC experience.
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to providing a workplace that is inclusive and respectful of all employees. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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Regulatory Affairs Specialist
3 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess...
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Regulatory Affairs Specialist
3 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess...
-
Regulatory Affairs Specialist
3 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Uxbridge, United Kingdom Regeneron Full time{"title": "CMC Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our global regulatory and CMC submissions.Key ResponsibilitiesReview and assess regulatory...
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Regulatory Affairs Specialist
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Uxbridge, United Kingdom Regeneron Full timeRegulatory Affairs SpecialistRegeneron is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory requirements and supporting the submission of regulatory documents.Key Responsibilities:Review and analyze regulatory...
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Regulatory Affairs Specialist
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeRegulatory Affairs SpecialistRegeneron is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory requirements and supporting the submission of regulatory documents.Key Responsibilities:Review and analyze regulatory...
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