PE Global
Regulatory Affairs Manager
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Regulatory Affairs Manager
PE Global is currently recruiting for a Regulatory Affairs Manager on behalf of a leading global biotechnology organisation. This is an excellent opportunity to join a high-performing European Regulatory Affairs team supporting innovative medicines from early clinical development through to commercialisation.
This hybrid position offers the flexibility to work primarily from home, with occasional travel to the Cambridge or Uxbridge office as required.
Contract Duration: 12 months
Rate: £47.41 per hour PAYE or £55.56 per hour Umbrella
The Role
As the Regulatory Affairs Manager, you will play a key role in ensuring products obtain and maintain the necessary regulatory approvals to support both clinical development and commercial marketing across Europe. Working within a collaborative international regulatory team, you will contribute to regulatory strategy, submissions, and lifecycle management across a diverse product portfolio.
Key Responsibilities
- Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities, in line with global strategies and regional requirements.
- Support the implementation of regulatory strategies and regulatory affairs activities for assigned products.
- Provide regulatory guidance on regional submission requirements and regulatory pathways.
- Contribute to the preparation of regional regulatory documentation and support interactions with regulatory authorities.
- Support regional labelling negotiations and lifecycle management activities.
- Participate in the development and execution of regional regulatory strategies.
- Assess regulatory risks and help develop mitigation plans.
- Monitor changes in regulatory legislation, guidance and policy across the region.
- Conduct regulatory research to support product development and registration activities.
- Evaluate the impact of evolving regulatory requirements and competitor activities on product strategy.
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Candidate Requirements
- A scientific degree or equivalent qualification.
- Demonstrated experience within Regulatory Affairs in the pharmaceutical or biotechnology industry.
- Strong understanding of regulatory legislation, policies, procedures and SOPs relating to medicinal products.
- Knowledge of regional regulatory procedures for clinical trials, marketing authorisations, post-approval variations, renewals and extensions.
- Good understanding of the drug development process.
- Experience working within the European regulatory environment.
- Excellent written and verbal communication skills.
- Ability to interpret and communicate scientific and clinical information effectively.
- Strong analytical and problem-solving skills with the ability to anticipate regulatory challenges and develop practical solutions.
- Excellent stakeholder management and collaboration skills.
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Please note: Our client cannot provide visa sponsorship. Applicants must already have the legal right to live and work in the UK.
Interested candidates should submit an updated CV for immediate consideration.
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