Senior Manager/Director of Regulatory Affairs

2 weeks ago

Petersfield Hampshire, United Kingdom Proclinical Staffing-PJP Full time

Job Description Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices.
Oversee the submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products.
- Ensure all submissions to regulatory authorities are of high quality and conducted in a professional and timely manner.
- Act as signatory for appropriate medical device technical file sections and expert reports.
- Represent Regulatory Affairs as part of Research & Development (R&D) project teams and lead regulatory strategy discussions.
- Lead and support regulatory due diligence of new products.
- Manage workload of team for assigned projects in line with business priorities.
- Medical Devices and related ISO activities.
- Support and manage regulatory officers in the performance of their day-to-day activities.
Experience in UK and EU pharmaceutical regulatory affairs.
- Experience of line management and/or leading a regulatory team.
- Good IT skills including MS Word, Excel and PowerPoint.
- Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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    Petersfield, Hampshire, United Kingdom Proclinical Staffing-PJP Full time

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    Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices....

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    Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices....

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    Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices. ...

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    Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices. ...

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