Senior Regulatory Affairs Specialist
3 weeks ago
We are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Regeneron Ireland DAC. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our products with global regulatory requirements.
Key Responsibilities- Review and assess regulatory submissions to ensure compliance with global regulatory requirements.
- Collaborate with cross-functional teams to support submission strategies and impact on supply and regulatory release processes.
- Support the development and maintenance of regulatory submission forms to ensure compliance with regulatory requirements.
- Foster strong communication and working relationships between internal stakeholders and external partners.
- Stay up-to-date with changes in regulatory requirements and ensure that our products remain compliant.
- Bachelor's degree in a relevant technical or scientific discipline.
- At least 4 years of experience in the pharmaceutical or biotech industry, with a minimum of 3 years of relevant CMC experience.
- Strong understanding of quality principles in a regulated manufacturing environment.
- Excellent communication and interpersonal skills.
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. Regeneron is an equal opportunity employer and welcomes applications from diverse candidates.
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Specialist – Regulatory Affairs PPP
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Specialist – Regulatory Affairs PPP
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United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
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United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
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United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
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Regulatory Support Officer
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Product Stewardship Specialist
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Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support our CMC development activities from a regulatory standpoint. The successful candidate will participate in cross-functional meetings, identify regulatory issues, and suggest strategies to mitigate risks.Key Responsibilities:Review...
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Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support our CMC development activities from a regulatory standpoint. The successful candidate will participate in cross-functional meetings, identify regulatory issues, and suggest strategies to mitigate risks.Key Responsibilities:Review...
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Ecotoxicology Risk Assessment Specialist
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Regulatory Affairs Specialist
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United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Senior Compliance OfficerCareer Opportunities at Regeneron Ireland DACJob Summary:We are seeking a highly skilled Senior Compliance Officer to join our team at Regeneron Ireland DAC. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory and CMC requirements.Key...
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Regulatory Affairs Specialist
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Senior Regulatory Affairs Manager
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United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Senior Reporting ManagerRegeneron Ireland DAC is seeking a highly skilled Senior Reporting Manager to join our team in Dublin or Amsterdam. As a key member of our EU Regulatory Affairs team, you will play a critical role in ensuring the company's compliance with emerging EU legislation and processes.Key Responsibilities:Lead and develop EU...
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Senior Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Senior Reporting ManagerRegeneron Ireland DAC is seeking a highly skilled Senior Reporting Manager to join our team in Dublin or Amsterdam. As a key member of our EU Regulatory Affairs team, you will play a critical role in ensuring the company's compliance with emerging EU legislation and processes.Key Responsibilities:Lead and develop EU...
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Regulatory Affairs Manager
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Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support the development and approval of gene therapies.Key Responsibilities:Participate in cross-functional meetings to discuss program-specific regulatory strategies.Identify and mitigate CMC regulatory risks.Review regulatory filing...
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Regulatory Affairs Advisor
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