Regulatory Affairs Manager in Cambridgeshire

Location: Cambridge

Salary: Hidden

Recruiter: Proclinical

Job Hours: Full-time

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Proclinical is seeking a Regulatory Affairs Manager. This role is pivotal in providing country-specific regulatory expertise and execution for the management of biotechnology products. The successful candidate will be responsible for coordinating and carrying out regulatory submissions in compliance with national regulatory requirements as well as the company's business standards. This role also involves supporting and executing local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application submissions and regulatory support for commercial activities.

Responsibilities:

Manage regulatory affairs and local regulatory strategy for a portfolio of products.

Ensure timely regulatory submissions that meet all regulatory requirements.

Contribute to and execute the filing plan for their country where applicable.

Represent regulatory on cross-functional brand or project teams and provide advice on local regulatory and compliance strategy.

Review promotional and non-promotional materials.

Maintain awareness of new & developing local legislation & regulatory policy and keep local management updated.

Participate in local regulatory process improvements initiatives.

Assist in Healthcare Compliance activities where applicable.

Coordinate and review briefing documents and/or other submissions for meetings with Regulatory agencies.

Collate, distribute, exchange and archive regulatory information with regulatory colleagues and give advice on local regulatory considerations.

Key Skills and Requirements:

Relevant Bachelor's degree.

Experience in/knowledge of developing and maintaining Clinical Trial Application (CTA) documentation in the EU.

Knowledge and awareness of the relevant regulatory guidelines and legislation.

Strong communication skills both oral and written.

Organizational skills & regulatory project management skills.

Experience within a biologics organisation (preferred).

Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice (preferred).

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About Proclinical

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At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.

Whether you are looking for a recruitment agency to support you with a single vacancy or you need to staff an entire new facility, we extend an expert hand to help you find the highly-skilled people you need.

Operating exclusively within life sciences industry – from MedTech and Medical Devices to Pharma and Biotech – our experience, resources and dedication enable us to meet the unique needs of the competitive, fast-paced industry.

Our worldwide connections match the rapid globalisation of the life science industry, with offices located throughout North America, Europe and the Asia Pacific region.

Because each type of role requires a unique skill-set and understanding, Proclinical Staffing is comprised of specialist teams, each dedicated to recruiting for specific job functions. By specialising, our teams of consultants have a greater understanding of the roles that they are recruiting for, and are able to source the very best talent within the industry.

Our specialist recruitment teams:

+ Regulatory Affairs
+ Clinical Research
+ Quality Assurance, Manufacturing & Validation
+ Medical Affairs & Physicians
+ Commercialisation & Business Development
+ Biometrics: SAS, Stats & Data Management
+ Computer Science & Data Science
+ Medical Writing & Medical Communications
+ Product Safety & Pharmacovigilance
+ HEOR and Market Access
+ Scientific & Preclinical
+ Technical Operations

If you are currently hiring or considering taking the next step in your career, call us today on +44(0)207 44 00 637 or visit www.proclinical.com for more information or to submit your CV online.