Interim Regulatory Affairs Manager

Practicus
Birmingham
2 months ago
Applications closed

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PROJECT DESIGN ENGINEER

Our client, aglobal pharmaceutical companycommitted to innovation and improving patient outcomes. They develop and deliver life-changing treatments and are seeking a Regulatory Affairs Manager on an Interim Basis to join a growing RA function.


📍 Location - Remote

📜 Contract - 6 months

đź’° Day rate - Up to ÂŁ400 per day (Inside IR35)


This role is crucial in ensuring the company's products meet regulatory requirements for approval and continued compliance in Europe. TheSenior Manager, Global Regulatory Affairswill oversee the submission and maintenance ofMarketing Authorisations (MAAs), act as a key point of contact with regulatory authorities (especially theEuropean 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

  • ARegulatory Affairs expertwith experience in pharmaceutical development and lifecycle management.
  • Astrong communicatorcomfortable engaging with regulatory authorities and internal stakeholders.
  • Adetail-oriented professionalwith problem-solving skills and a deep understanding of European regulatory requirements.

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