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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 with 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
Network with professionals in the pharmaceutical industry, especially those who have experience in regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory compliance.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks relevant to the role, particularly EU regulations like MRP, DCP, and NP. This knowledge will not only boost your confidence but also demonstrate your commitment to understanding the complexities of the position.
✨Tip Number 3
Prepare to discuss your experience with lifecycle management and CMC dossiers during interviews. Be ready to share specific examples of how you've successfully navigated regulatory challenges and contributed to product approvals in the past.
✨Tip Number 4
Showcase your leadership skills by highlighting any previous mentoring or team management experiences. Emphasise your ability to guide a team through complex regulatory processes, as this is a key aspect of the Senior Regulatory Lead role.
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 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 collaborative environment.
Highlight Continuous Learning: Mention any recent training or courses you've undertaken to stay updated on regulatory guidelines and best practices. This shows your commitment to maintaining up-to-date knowledge in the field, which is essential for the Senior Regulatory Lead position.
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 leadership experiences. Talk about how you've guided teams in the past, provided training, and managed performance effectively.
✨Familiarise Yourself with Current Regulations
Stay updated on the latest EU regulatory requirements and guidelines. During the interview, you might be asked about recent changes or best practices, so showing that you're knowledgeable will set you apart.
✨Prepare for Cross-Functional Collaboration Questions
The role requires collaboration with various teams. Think of examples where you've worked with Quality, Supply Chain, or Commercial teams to achieve business objectives, and be ready to discuss these experiences.
