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For Companies At a Glance
- Tasks: Lead a dynamic regulatory team, managing compliance and strategy for global markets.
- Company: Join a forward-thinking pharmaceutical company dedicated to innovation and quality.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Why this job: Make an impact in the pharmaceutical industry while mentoring a passionate team.
- Qualifications: Experience in Regulatory Affairs and strong knowledge of EU regulations required.
- Other info: Ideal for those who thrive in fast-paced, collaborative environments.
The predicted salary is between 43200 - 72000 £ per year.
Job Description
We are seeking a Regulatory leader to head a small and dynamic regulatory group. The role is a mix of development, LCM and strategy.
Key Responsibilities
- Manage regulatory activities related to mature products across multiple global markets, ensuring compliance with local regulations
- Prepare, submit, and maintain variations, renewals, labelling updates, and CMC (Chemistry, Manufacturing & Controls) dossiers.
- Liaise with global health authorities and internal stakeholders to ensure timely approvals and regulatory compliance.
- Develop and execute regulatory strategies for MAA and lifecycle management, identifying opportunities for process improvements.
- Lead and mentor a small team of regulatory professionals, providing guidance, training, and performance management.
- Maintain up-to-date knowledge of regulatory guidelines and requirements, ensuring best practices are followed.
- Collaborate with cross-functional teams, including Quality, Supply Chain, and Commercial teams, to support business objectives.
Key Requirements
- Experience in Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of EU regulatory requirements (MRP, DCP, NP).
- Small molecule expertise
- MDR understanding
- Experience with CMC, variations, renewals, and labelling updates.
- Excellent communication and stakeholder management skills.
- Ability to work effectively in a fast-paced, collaborative environment.
Senior Regulatory Lead employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Lead
✨Tip Number 1
Familiarise yourself with the latest EU regulatory requirements, especially around MRP, DCP, and NP. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, particularly those who have experience in small molecules and CMC. Engaging with industry peers can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory activities in the past. Highlighting your experience with variations, renewals, and labelling updates will showcase your expertise.
✨Tip Number 4
Demonstrate your leadership skills by sharing experiences where you've mentored or guided a team. This is crucial for the Senior Regulatory Lead position, as you'll be expected to lead a small team effectively.
We think you need these skills to ace Senior Regulatory Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, particularly within the pharmaceutical industry. Emphasise your knowledge of EU regulatory requirements and any specific achievements related to managing regulatory activities.
Craft a Compelling Cover Letter: In your cover letter, address how your background aligns with the key responsibilities of the Senior Regulatory Lead role. Mention your experience with CMC, variations, renewals, and labelling updates, and provide examples of how you've successfully led teams or projects.
Showcase Communication Skills: Since excellent communication and stakeholder management skills are crucial for this role, include specific instances where you effectively liaised with health authorities or collaborated with cross-functional teams. This will demonstrate your ability to thrive in a fast-paced environment.
Highlight Continuous Learning: Mention any recent training or certifications related to regulatory guidelines and requirements. This shows that you are committed to maintaining up-to-date knowledge and following best practices in the field.
How to prepare for a job interview at Discover International
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience in Regulatory Affairs, especially within the pharmaceutical industry. Be prepared to discuss specific examples of how you've managed regulatory activities and ensured compliance with local regulations.
✨Demonstrate Leadership Skills
Since the role involves leading and mentoring a team, be ready to share your experiences in guiding and training others. Discuss your approach to performance management and how you foster a collaborative environment.
✨Prepare for Technical Questions
Expect questions related to EU regulatory requirements, CMC, and lifecycle management. Brush up on your knowledge of MRP, DCP, and NP processes, and be ready to explain how you've applied this knowledge in past roles.
✨Emphasise Communication Skills
Strong communication and stakeholder management skills are crucial for this position. Prepare examples that demonstrate your ability to liaise effectively with global health authorities and cross-functional teams, ensuring timely approvals and compliance.
