Interim Regulatory Affairs Manager

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Interim Regulatory Affairs Manager, United Kingdom

Client:

Practicus

Location:

Remote

Job Category:

Other

EU work permit required:

Yes

Job Views:

5

Posted:

30.03.2025

Expiry Date:

14.05.2025

Job Description:

Our client, a global pharmaceutical company committed to innovation and improving patient outcomes, is seeking a Regulatory Affairs Manager on an Interim Basis to join a growing RA function.

Contract: 6 months
Day rate: Up to £400 per day (Inside IR35)

This role is crucial in ensuring the company's products meet regulatory requirements for approval and continued compliance in Europe. The Senior Manager, Global Regulatory Affairs will oversee the submission and maintenance of Marketing Authorisations (MAAs), act as a key point of contact with regulatory authorities (especially the European Medicines Agency), and provide strategic regulatory guidance throughout a product’s lifecycle.

What You’ll Do

• Lead Regulatory Strategies – Drive the approval and ongoing compliance of pharmaceutical products by managing regulatory submissions, responses to authorities, and lifecycle maintenance.
• Ensure Compliance – Stay updated on regulatory changes, maintain company standards, and provide guidance to internal teams.
• Regulatory Liaison – Serve as the primary contact for European regulators, ensuring smooth communication and approvals.
• Cross-Functional Collaboration – Work with teams across clinical, pharmacovigilance, and brand management to align regulatory strategies with business goals.
• Drive Continuous Improvement – Enhance internal processes, contribute to regulatory intelligence, and support compliance initiatives.

Who We Need

• A Regulatory Affairs expert with experience in pharmaceutical development and lifecycle management.
• A strong communicator comfortable engaging with regulatory authorities and internal stakeholders.
• A detail-oriented professional with problem-solving skills and a deep understanding of European regulatory requirements.