Regulatory Affairs Executive - Contract

Job Title: Regulatory Affairs Executive

Location: London

Duration: 6 Months

The Client: Global Pharma Company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Be part of the Medical/Regulatory team working on EU and Rest of World territories for the P3 project. Determine all products within the Company (worldwide marketing authorisations) that require updates from a regulatory perspective
Execute regulatory strategies for European and International submissions
Responsible for the preparation, review and management of documentation (i.e. annotated SPCs and PILs, clinical expert statements and literature) to support relevant variation submissions to the local regulatory authorities
Electronic variation compilation in line with eCTD or NeeS format
Harmonisation of SPC/PIL for different countries (particularly EU and outside of EU), as per the regulatory requirements/variation
Annotate SPCs and PILs from a regulatory perspective having a strong understanding of QRD/non-QRD requirements
Participate in interactions with regulatory authorities, negotiating requirements as required
Follow defined work flow processes within the company Regulatory Document Management System
Manage Requests for Further Information from Regulatory Agencies
Oversight of the P3 change control process to execute the required safety variations (i.e. regulatory impact assessment of present and proposed documentation)
Collaborate with regulatory partners, company medics and consultants for regulatory and scientific advice
Work with an international-based team and be confident with communicating and collaborating with internal and external colleagues

Full details available on application

The Candidate:

Previous experience

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

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