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- Tasks: Lead regulatory strategy for pharmaceutical products and ensure compliance across Europe.
- Company: Join a dynamic team at Blackfield Associates, a leader in regulatory affairs.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while shaping regulatory strategies.
- Qualifications: 7+ years in regulatory affairs with strong knowledge of European frameworks.
- Other info: Collaborate with cross-functional teams in a fast-paced, innovative environment.
The predicted salary is between 60000 - 84000 £ per year.
Overview: Senior Regulatory Affairs Manager CMC – Europe – Slough (Hybrid). Full time, Permanent. This position supports and coordinates regulatory activities for both specialty and generic pharmaceutical products across Europe. The role involves strategic input into development programs, preparation and submission of regulatory documentation, and post-approval lifecycle management and due diligence reviews. You will work cross-functionally with internal teams and external partners to ensure timely and compliant submissions to EMA and national authorities.
Key Responsibilities:
- Lead regulatory strategy development for new and existing products, including De-centralised/orphan and generic submissions.
- Review non-clinical and clinical data packages for regulatory adequacy and compliance.
- Conduct due diligence across CTD Modules 1–5 and review sections of Marketing Authorisation Applications (MAAs).
- Coordinate registration and maintenance of assigned generic products.
- Support regulatory authority interactions, including scientific advice procedures.
- Maintain regulatory databases and document management systems.
- Guide junior staff and contribute to process improvements within the regulatory function.
- Ensure alignment with EU regulatory requirements for product launch and lifecycle activities.
Required Experience & Qualifications:
- Strong, clear evidenced experience with European regulatory frameworks and submission pathways (DCP, MRP, national procedures).
- Proven experience in regulatory strategy development for specialty and generic products - minimum 7 years industry experience.
- Hands-on experience with post-approval activities, variation strategies, line extensions and due diligence activities is essential.
- Familiarity with regulatory tools and platforms (eCTD, CESP, MHRA portal, Eudralink).
- Ability to critically evaluate scientific data and identify regulatory risks and mitigation strategies.
- Degree or higher qualification in Pharmacy, Life Sciences, or a related field.
- Excellent communication, project management, and cross-functional collaboration skills.
- Experience managing regulatory timelines and approvals in a fast-paced environment.
Senior Manager Regulatory Affairs CMC - Blackfield Associates in Slough employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs CMC - Blackfield Associates in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with European frameworks. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory strategies and compliance. Be ready to discuss your hands-on experience with post-approval activities and how you've tackled challenges in the past.
✨Tip Number 3
Showcase your project management skills! During interviews, highlight specific examples where you successfully managed regulatory timelines and collaborated with cross-functional teams to achieve compliance.
✨Tip Number 4
Don't forget to apply through our website! We love seeing candidates who are genuinely interested in joining us at StudySmarter. Tailor your application to reflect your passion for regulatory affairs and how you can contribute to our team.
We think you need these skills to ace Senior Manager Regulatory Affairs CMC - Blackfield Associates 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 European regulatory frameworks and any specific projects that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can contribute to our team. Be sure to mention your experience with strategic development and post-approval activities, as these are key for us.
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Did you lead a successful submission or improve a process? We love to see quantifiable results that demonstrate your impact in previous roles.
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’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Jobster
✨Know Your Regulatory Frameworks
Make sure you brush up on your knowledge of European regulatory frameworks and submission pathways. Be prepared to discuss specific examples from your experience that demonstrate your understanding of DCP, MRP, and national procedures.
✨Showcase Your Strategic Thinking
During the interview, highlight your experience in developing regulatory strategies for both specialty and generic products. Share concrete examples of how you've led strategy development and what impact it had on product submissions.
✨Prepare for Technical Questions
Expect questions about your hands-on experience with post-approval activities and due diligence. Be ready to explain how you've evaluated scientific data and identified regulatory risks in past projects.
✨Demonstrate Cross-Functional Collaboration
Since this role involves working with various teams, be prepared to discuss how you've successfully collaborated with internal teams and external partners. Share specific instances where your communication and project management skills made a difference.
