Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory submissions and collaborate with teams on innovative drug applications.
- Company: Fast-growing pharmaceutical company with a dynamic work culture.
- Benefits: Permanent position, hybrid working, and opportunities for career advancement.
- Why this job: Make a real impact in the pharmaceutical industry while working on exciting new products.
- Qualifications: 7+ years in Regulatory Affairs with experience in EU requirements and MAA submissions.
- Other info: Join a rapidly expanding team and thrive in a fast-paced environment.
The predicted salary is between 36000 - 60000 £ per year.
Blackfield Associates are supporting a fast moving pharmaceutical company who, due to consistent growth, are looking for an experienced Senior Regulatory Affairs Manager, who will lead interactions with the health authorities and manage new MAA/new drug applications.
We are looking for an expert in DCP cycles, able to author dossiers. As Senior Regulatory Affairs Manager, you will:
- Review and assess adequacy of the non‐clinical and clinical data package for regulatory submission based on available scientific guidance, precedence, previous experience and any scientific communication with any health authority if available specific to the development program.
- Seek clarification from the developer to make informed decisions, work cross-functionally to assess risks/mitigation, and assess need that may benefit from any further regulatory HA interaction.
- Actively be involved in due diligence of the dossier covering modules 1 to 5 and will be responsible for assessing adequacy of these sections and any responses to questions during review.
- Work collaboratively with internal stakeholders and external stakeholders to finalise sections of MAA.
- Contribute actively in any future development plans by working closely with the new products team to define regulatory strategy required to support MAA.
- Support post‐approval regulatory activities to ensure timely preparation of various documents and studies required by EMA for an EU orphan registered product.
- Work closely with internal teams and other CROs supporting these efforts.
- Support the coordination and registration of assigned generic products in coordination with the internal teams.
To be considered for the role of Senior Regulatory Affairs Manager, you will have:
- A minimum of 7 years experience in Regulatory, working hands-on with new/initial indications and new MAA.
- Proven experience with EU regulatory requirements, particularly with Decentralised Procedures.
- Clear experience gained from managing product lifecycle, including Marketing Authorisation submissions (DCPs, MRPs), set up and implement post‐approval line‐extension and variation strategies, maintenance activities.
- The right candidate will be a technical, autonomous individual with ambition and comfortable with a fast-paced regulatory environment.
This is a permanent, full-time position based in Slough. This role is an individual contributor, working in a matrix environment with rapid expansion. Hybrid working. All candidates must have the valid right to work; this opportunity is unable to sponsor.
Senior Manager Regulatory Affairs in London employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of DCP cycles and MAA submissions. Be ready to discuss your past experiences and how they relate to the role. We want to see your expertise shine!
✨Tip Number 3
Showcase your collaborative skills! Highlight examples where you've worked cross-functionally with teams to achieve regulatory goals. This is key in a fast-paced environment like the one we're in.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace Senior Manager Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. Highlight your experience with MAA submissions and DCP cycles, as these are key for us. Use specific examples that showcase your expertise in regulatory affairs.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Mention your hands-on experience with EU regulatory requirements and how you've successfully managed product lifecycles. Keep it engaging and personal!
Showcase Your Collaborative Skills: Since this role involves working closely with various stakeholders, make sure to highlight your teamwork skills. Share examples of how you've collaborated with internal teams or CROs to achieve regulatory goals. We love a team player!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulatory requirements, especially around Decentralised Procedures. Be ready to discuss your hands-on experience with new MAA submissions and how you've managed product lifecycles in the past.
✨Prepare for Scenario Questions
Expect questions that ask you to assess the adequacy of non-clinical and clinical data packages. Think about specific examples where you had to seek clarification from developers or work cross-functionally to mitigate risks.
✨Show Your Collaborative Spirit
This role involves working closely with both internal and external stakeholders. Be prepared to share examples of how you've successfully collaborated in the past, particularly in finalising sections of MAAs or coordinating with CROs.
✨Demonstrate Your Strategic Thinking
Talk about your experience in contributing to future development plans and defining regulatory strategies. Highlight any instances where your strategic input made a significant impact on a project or submission.
