At a Glance
- Tasks: Lead regulatory activities for clinical trials and provide strategic guidance across development programmes.
- Company: Join a leading global biotechnology organisation making a difference in healthcare.
- Benefits: Competitive salary, hybrid work model, and the chance to shape clinical development.
- Other info: Contract role with immediate start; must be UK-based and within commuting distance to West London.
- Why this job: Be a key player in innovative clinical research and regulatory excellence.
- Qualifications: Master's degree and 5+ years in Regulatory Affairs, ideally in biotech or pharma.
The predicted salary is between 70000 - 90000 £ per year.
Job Title
Senior Manager, Regulatory Affairs/ Consultant (CTAs)
Job Type
12-Month Contract
Location
- West London, UK – Hybrid
- Please note that this is a 12 Month Contract opportunity
Cpl Life Sciences is partnering with a leading global biotechnology organisation to recruit an experienced Senior Manager, Regulatory Affairs to support a growing portfolio of clinical development programmes across Immunology, Inflammation and Genetics.
This is an exciting opportunity for a regulatory professional with strong European clinical regulatory expertise to take ownership of clinical trial applications, support the start-up of new studies, and provide strategic regulatory leadership across multiple development programmes.
The successful candidate will work closely with global development teams and oversee interactions with external CRO partners to ensure regulatory excellence throughout the clinical trial lifecycle.
Key Responsibilities
- Act as a key regulatory expert for Europe, strengthening the organisation's regulatory presence and providing regional expertise to global regulatory and development teams.
- Lead all regulatory activities associated with clinical trial start-up and maintenance across Europe, including:
- Clinical Trial Applications (CTAs)
- Regulatory submissions and amendments
- Responses to health authority questions
- Compliance and regulatory maintenance activities
- Partner with clinical and cross-functional teams to ensure timely study initiation and ongoing study conduct.
- Represent the organisation in interactions with multiple Contract Research Organisations (CROs) supporting a diverse portfolio of clinical studies.
- Identify and leverage innovative European regulatory pathways and opportunities to accelerate development programmes.
- Provide strategic regulatory guidance across both early-stage and late-stage clinical development programmes.
- Monitor and interpret emerging EU regulations, legislation and guidance, ensuring organisational awareness and compliance where applicable.
- Collaborate with the Senior Director of Regulatory Affairs and broader leadership team to support programme progression and key development milestones.
- Contribute to continuous improvement of regulatory processes and ways of working across the organisation.
- Candidate Profile
- Master's Degree in Life Sciences, Pharmacy, Regulatory Affairs or a related scientific discipline.
- Minimum 5 years' experience within Regulatory Affairs, ideally within the biotechnology or pharmaceutical industry.
- Strong experience supporting European clinical development programmes and clinical trial applications.
- Thorough understanding of EU clinical trial regulations, regulatory frameworks and submission processes.
- Experience working with CRO partners and managing external regulatory activities.
- Proven ability to work independently and lead regulatory activities across multiple programmes.
- Experience supporting both early and late-phase clinical development would be highly advantageous.
- Strong stakeholder management and communication skills, with the ability to influence cross-functional teams.
Please note that this is a contract role, looking for someone to start ASAP, so please ensure you have a maximum of a 4-week notice.
Anyone with a longer notice period won’t be considered.
You MUST also be based in the UK and within a commutable distance to the UK office in West London.
- For more information, please contact lucy. kirkaldy@cpl. com
- #J-18808-Ljbffr
Senior Manager, Regulatory Affairs CTAs (Contract) employer: Cpl Healthcare
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