Regulatory Affairs Manager
2 months ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory team, you will play a vital role in ensuring compliance with regulatory requirements for our clients.
Key Responsibilities- Develop Regulatory Strategies: Create and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
- Regulatory Assessments: Assess change controls and provide regulatory assessments of quality changes in production and quality control.
- Submission Preparation: Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control, and quality assurance.
- Content Development: Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
- Project Management: Manage projects within Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
- Risk Management: Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
- Education: University-level education in Life Sciences or equivalent by experience.
- Experience: Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
- Knowledge: Strong understanding of CMC and post-approval regulatory requirements.
- Skills: Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
- Language: Fluent in English (written and spoken). French, Italian, and German would be a strong plus.
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Regulatory Affairs Manager
1 month ago
Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs Manager Job DescriptionPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. The ideal candidate will have experience in Regulatory Affairs and Compliance, particularly within the pharmaceutical industry.Key Responsibilities:Develop and contribute to high-quality...
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Regulatory Affairs Manager
1 month ago
Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs Manager Job DescriptionPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. The ideal candidate will have experience in Regulatory Affairs and Compliance, particularly within the pharmaceutical industry.Key Responsibilities:Develop and contribute to high-quality...
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Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs Manager OpportunityPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. As a key member of the regulatory team, you will provide strategic guidance and support to ensure compliance with global regulatory requirements.Key Responsibilities:Develop and maintain...
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Uxbridge, United Kingdom Park Street People Full timeRegulatory Affairs ManagerAn innovative global pharmaceutical company is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract.As a key member of the regulatory team, you will provide strategic guidance and support to ensure compliance with regulatory requirements across the region.Key...
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