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- Tasks: Lead regulatory strategies and ensure compliance for established pharmaceutical products.
- Company: Join a top-tier pharmaceutical company driving healthcare innovation globally.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and collaboration.
- Why this job: Make a real impact in healthcare while working with diverse teams and experts.
- Qualifications: Advanced degree in life sciences and expertise in regulatory affairs required.
- Other info: Proclinical is a leading recruiter in life sciences, dedicated to matching talent with top positions.
The predicted salary is between 43200 - 72000 £ per year.
Help bring science to life and join a leading pharmaceutical company where you can play a key role within Regulatory Affairs and assist in driving healthcare innovation! This position will ensure compliance with regional and global regulatory requirements for established products. You will develop and implement regulatory strategies, lead interactions with regulatory agencies, and manage a regulatory team. This role focuses on maintaining compliance and addressing regulatory changes in global markets.
Responsibilities:
- Develop and implement regional and global regulatory strategies for established products.
- Lead and manage interactions with regulatory authorities.
- Collaborate with commercial, MSAT, CMC, Supply Chain, Medical Affairs, and Pharmacovigilance teams.
- Ensure compliance with internal processes and external regional regulatory requirements.
- Monitor and address regulatory changes in global markets and share knowledge.
- Lead and coach regulatory professionals, providing feedback and defining clear objectives aligned with company goals.
- Make responsible decisions to drive team performance.
Key Skills and Requirements:
- Advanced degree in life sciences.
- In-depth knowledge of European, UK, and ROW regulatory environments, particularly CMC requirements.
- Expertise in developing and maintaining medicine registrations in EU and UK.
- Significant experience managing lifecycle regulatory activities for established products.
- Expert knowledge of regulatory affairs in infectious disease and internal medicines.
- Sound knowledge of quality and clinical guidelines in EU and the UK.
- Hands-on experience leading technology and marketing authorization transfers in EU.
- Proven experience with EU regulatory procedures, especially MRP/DCP/CP and NP.
- Effective collaboration within CMC teams and matrix environments.
Regulatory CMC Lead employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory CMC Lead
✨Tip Number 1
Familiarise yourself with the latest regulatory changes in the EU and UK, especially those related to CMC requirements. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, particularly those who have experience in managing lifecycle activities for established products. Engaging with industry peers can provide valuable insights and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led interactions with regulatory authorities in the past. Highlighting your hands-on experience with MRP/DCP/CP and NP procedures will set you apart from other candidates.
✨Tip Number 4
Showcase your leadership skills by preparing to talk about how you've coached and developed regulatory professionals in previous roles. Emphasising your ability to drive team performance aligns well with the responsibilities of the Regulatory CMC Lead position.
We think you need these skills to ace Regulatory CMC Lead
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory CMC Lead position. Tailor your application to highlight your relevant experience in regulatory affairs, particularly in CMC requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasise your advanced degree in life sciences and any significant experience you have managing lifecycle regulatory activities for established products. Mention specific examples of your expertise in EU and UK regulatory environments.
Showcase Leadership Skills: Since this role involves leading a regulatory team, be sure to include examples of your leadership experience. Discuss how you've coached professionals, provided feedback, and defined objectives that align with company goals.
Tailor Your Application: Customise your application documents to reflect the key skills and requirements mentioned in the job description. Use keywords from the listing, such as 'collaboration', 'compliance', and 'regulatory strategies' to demonstrate your fit for the role.
How to prepare for a job interview at Proclinical Staffing
✨Showcase Your Regulatory Knowledge
Make sure to highlight your in-depth understanding of European, UK, and ROW regulatory environments during the interview. Be prepared to discuss specific CMC requirements and how you've successfully navigated them in past roles.
✨Demonstrate Leadership Skills
As this role involves leading a regulatory team, be ready to share examples of how you've coached and developed team members in previous positions. Discuss your approach to setting clear objectives and driving team performance.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world regulatory scenarios. Think about challenges you've faced in managing lifecycle regulatory activities and how you addressed them effectively.
✨Emphasise Collaboration Experience
This position requires collaboration with various teams. Be prepared to discuss your experience working within CMC teams and matrix environments, highlighting successful projects where teamwork was key to achieving regulatory compliance.
