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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 compliance.
- Benefits: Enjoy flexible working options, professional development opportunities, and a supportive team culture.
- 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 and CMC processes required.
- Other info: Opportunity to collaborate with cross-functional teams and drive process improvements.
The predicted salary is between 48000 - 72000 £ per year.
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 Regulatory Affairs, 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 managed regulatory activities in the past. Highlighting your experience with variations, renewals, and labelling updates will showcase your expertise and readiness for the role.
✨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 and develop a small team.
We think you need these skills to ace Senior Regulatory Lead
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Lead position. Tailor your application to highlight your relevant experience in regulatory affairs, particularly within the pharmaceutical industry.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with EU regulatory requirements, CMC, and lifecycle management. Provide specific examples of how you've managed regulatory activities and liaised with health authorities in previous roles.
Showcase Leadership Skills: Since the role involves leading and mentoring a team, be sure to include any leadership or mentoring experiences you have. Discuss how you've guided teams in the past and contributed to their professional development.
Tailor Your Application: Customise your cover letter to reflect your understanding of the company's goals and how your skills align with their needs. Mention any process improvements you've implemented in previous roles that could benefit the company.
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 EU regulations.
✨Demonstrate Leadership Skills
Since the role involves leading a small team, be ready to share your experiences in mentoring and guiding others. Discuss your approach to performance management and how you foster a collaborative environment.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world regulatory scenarios. Think about past challenges you've faced and how you developed strategies for MAA and lifecycle management.
✨Stay Updated on Regulatory Changes
Show your commitment to staying informed about the latest regulatory guidelines and requirements. Mention any recent changes in regulations that could impact the role and how you would adapt to them.
