Hays
Regulatory Affairs Manager EU
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Regulatory Affairs Manager EU, clinical trials, post approval
Your new company An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join a leading global biotechnology organisation. Working within the European Regulatory Affairs team, you will play a critical role in supporting the development, approval and life cycle management of innovative medicines across a diverse portfolio spanning metabolic, cardiovascular, inflammatory, endocrine and bone diseases, as well as biosimilars.
This role offers the opportunity to work on products from early clinical development through to marketing authorisation and post-approval activities, collaborating with cross-functional teams across Europe and globally.
Your new role As a key member of the Regulatory Affairs function, you will be responsible for supporting regional regulatory strategies and ensuring the successful planning and execution of regulatory submissions in line with business objectives and evolving regulatory requirements.
Key Responsibilities
- Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities.
- Support the implementation of regional regulatory strategies across a portfolio of development and commercial products.
- Provide regulatory expertise and guidance to cross-functional teams on European regulatory requirements and pathways.
- Contribute to the development of regulatory documentation and support interactions with health authorities.
- Advise on regulatory mechanisms that can accelerate product development, including orphan designation, fast track pathways, paediatric plans and compassionate use programmes.
- Support labelling activities and negotiations with regulatory agencies.
- Assess regulatory risks and opportunities, helping to shape product development and life cycle strategies.
- Monitor changes in legislation, guidelines and regulatory policy, evaluating their impact on product development and commercialisation.
- Conduct regulatory research and analyse precedent cases to support strategic decision-making.
- Track competitor activities and regulatory trends within the therapeutic landscape.
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What you'll need to succeed We are seeking an ambitious and motivated Regulatory Affairs professional with:
Essential Requirements
- Degree in a scientific discipline, Life Sciences or related field.
- Previous experience within Regulatory Affairs in the pharmaceutical or biotechnology industry.
- Strong understanding of European regulatory procedures for clinical trials and marketing authorisations.
- Knowledge of medicinal product legislation and regulatory guidelines.
- Understanding of drug development and product life cycle management.
- Experience working within a regional regulatory environment.
- Excellent written and verbal communication skills.
- Ability to interpret and communicate complex scientific and clinical information.
- Strong problem-solving skills with the ability to identify risks and develop effective solutions.
- Proven ability to build positive relationships and influence stakeholders across functions.
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What you'll get in return
- Remote working with once per month onsite presence
What you need to do now
- Join a world-leading biotechnology organisation with a strong pipeline of innovative therapies.
- Work on cutting-edge products that improve patient outcomes globally.
- Gain exposure to a broad range of regulatory activities across development and commercial portfolios.
- Collaborate with highly skilled international teams in a supportive and inclusive environment.
- Enjoy excellent career development opportunities within a global organisation.
If you are a Regulatory Affairs professional looking to take the next step in your career and contribute to bringing innovative medicines to patients across Europe, we would love to hear from you.
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