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- Tasks: Lead regulatory submissions and collaborate with teams to ensure compliance and success.
- Company: Fast-growing pharmaceutical company with a dynamic and innovative 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 drug applications.
- Qualifications: 7+ years in Regulatory Affairs with experience in EU regulations and MAA submissions.
- Other info: Join a rapidly expanding team and thrive in a fast-paced environment.
The predicted salary is between 48000 - 72000 £ 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're 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, 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 to assess 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:
- 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 Slough 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 Slough
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can get you in the door.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. We want you to show them you’re genuinely interested and ready to contribute to their growth in regulatory affairs.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs, especially around MAA submissions and DCP cycles. We want you to sound confident and knowledgeable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Senior Manager Regulatory Affairs in Slough
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 is your chance to shine! Explain why you're the perfect fit for our fast-paced environment. Mention your hands-on experience with EU regulatory requirements and how you’ve successfully managed product lifecycles in the past.
Showcase Your Collaboration Skills: We love team players! In your application, emphasise your ability to work cross-functionally with internal and external stakeholders. Share examples of how you've collaborated on regulatory strategies or MAA finalisation to demonstrate your teamwork skills.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
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 drug applications and how you've managed product lifecycles in the past.
✨Prepare for Technical Questions
Expect to dive deep into technical discussions about MAA submissions and dossier authoring. Prepare examples from your previous roles where you assessed clinical data packages or interacted with health authorities to showcase your expertise.
✨Show Your Collaborative Spirit
This role involves working closely with various internal and external stakeholders. Be prepared to share examples of how you've successfully collaborated in a matrix environment and how you’ve contributed to cross-functional teams in your past positions.
✨Demonstrate Your Problem-Solving Skills
Regulatory affairs can be fast-paced and challenging. Think of specific instances where you identified risks and implemented mitigation strategies. Highlight your ability to make informed decisions under pressure and how you’ve navigated complex regulatory landscapes.
