At a Glance
- Tasks: Lead and mentor a team in executing global regulatory strategies for clinical-stage projects.
- Company: Dynamic oncology biotech organisation with a focus on innovation.
- Benefits: Hybrid working, potential for permanent role, and professional development opportunities.
- Other info: Join a collaborative environment with opportunities for growth and process improvement.
- Why this job: Make a real impact in the biotech field while leading a passionate team.
- Qualifications: Extensive experience in Regulatory Affairs with strong leadership skills.
The predicted salary is between 63000 - 77000 £ per year.
12-Month Contract | Hybrid Working | Potential to Convert Permanent
About the Role
I am supporting an Oncology biotechnology organisation seeking an experienced Regulatory Affairs leader to oversee the execution of global regulatory activities across a clinical-stage portfolio.
This role requires a strong people leader with proven experience delivering US and EU regulatory submissions, leading regulatory teams, and ensuring successful execution of regulatory strategies across multiple development programmes.
Key Responsibilities
- Lead, mentor and develop a team of Regulatory Affairs professionals.
- Drive the execution of regulatory strategies across US, EU and international markets.
- Oversee the preparation, review and delivery of regulatory submissions, including INDs, CTAs, BLAs and MAAs.
- Ensure high-quality, compliant and timely submission delivery.
- Partner with cross-functional teams to support development and regulatory objectives.
- Provide regulatory guidance, risk assessment and issue resolution throughout the submission process.
- Lead resource planning, workload allocation and team development.
- Support interactions with health authorities and manage regulatory commitments.
- Drive process improvements and operational excellence across the regulatory function.
Experience Required
- Significant Regulatory Affairs experience within biotech, pharmaceutical or CRO environments.
- Strong experience with US and EU regulatory submissions.
- Proven track record delivering INDs, CTAs, BLAs and MAAs.
- Experience leading and developing regulatory teams.
- Strong understanding of global clinical development and regulatory requirements.
- Ability to translate regulatory strategy into successful execution and delivery.
- Excellent stakeholder management and cross-functional leadership skills.
This opportunity is ideally suited to a regulatory leader who combines strong submission expertise with people leadership and a hands-on approach to regulatory execution.
Regulatory Affairs Director Contract - Execution team in London employer: Hays Specialist Recruitment Limited Careers
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Contact Details:
Hays Specialist Recruitment Limited Careers Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Director Contract - Execution team in London
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We think you need these skills to ace Regulatory Affairs Director Contract - Execution team in London
Some tips for your application 🫡
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How to prepare for a job interview at Hays Specialist Recruitment Limited Careers
✨Brush Up on Lab Techniques
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Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
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