Strategic Regional Regulatory Affairs Lead

Kelly Science, Engineering, Technology & Telecom

England

On-site

GBP 70,000 - 110,000

Full time

7 days ago
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Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Affairs Manager to support the regulatory lifecycle of medicinal products across designated markets, ensuring compliance and effective lifecycle management. You will collaborate with global teams to develop regional regulatory strategies and submissions.

The role requires experience in regulatory affairs within pharma/biotech, strong stakeholder communication, and the ability to interpret scientific data for regulatory

Qualifications

  • Degree in pharmacy, pharmaceutical sciences, biology, chemistry, or related life science.
  • Demonstrated experience in regulatory affairs or a comparable role within pharma/biotech.
  • Understanding of regional regulatory pathways for clinical trials, marketing authorisations, and lifecycle changes.
  • Strong written and verbal communication skills; ability to present complex information clearly.
  • Experience navigating regulatory policies, SOPs, and quality/compliance processes.

Responsibilities

  • Develop, coordinate, and manage regional regulatory submissions including clinical trial applications and marketing authorisations.
  • Provide regulatory input and content guidance for regional documentation and health authority meetings.
  • Advise on regional regulatory pathways and mechanisms to facilitate product development.
  • Contribute to product labelling discussions balancing evidence and regulatory requirements.
  • Coordinate regulatory agency interactions and ensure local obligations are fulfilled.
  • Lead or supervise regional regulatory colleagues and support staff where appropriate.

Skills

Regulatory leadership
Regulatory submissions
Stakeholder management
Regulatory intelligence
Scientific communication

Education

Bachelor's degree in pharmacy/ life sciences

Tools

Regulatory databases

Job description

Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Affairs Manager to support the regulatory lifecycle of medicinal products across designated markets, ensuring compliance and effective lifecycle management. You will collaborate with global teams to develop regional regulatory strategies and submissions.

The role requires experience in regulatory affairs within pharma/biotech, strong stakeholder communication, and the ability to interpret scientific data for regulatory

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