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- Tasks: Lead regulatory strategies and oversee submissions for global pharmaceutical products.
- Company: Join a mid-sized pharma company dedicated to innovative therapies and regulatory excellence.
- Benefits: Enjoy a hybrid work model and the chance to impact global health positively.
- Why this job: Be at the forefront of drug development, shaping the future of healthcare.
- Qualifications: Proven leadership in Regulatory CMC and expert knowledge of EMA and FDA requirements.
- Other info: Contact rhi@greenlsr.com to apply and start your journey in pharma innovation.
The predicted salary is between 72000 - 108000 £ per year.
Our client, a mid-sized pharmaceutical company, are looking for an Executive Regulatory CMC Director (Small molecule focus) with a passion for leadership, driving strategy, ensuring compliance with EMA and FDA regulations, whilst fostering innovation and operational excellence.
The company is based in the London area and covers a number of therapeutic areas in small and large molecule products. They are dedicated to developing cutting-edge therapies that improve lives, have a strong global footprint, and are committed to regulatory excellence and delivering high-quality products to patients worldwide.
As Executive Director of Regulatory CMC, you will:
- Lead CMC regulatory strategies for global submissions (EMA, FDA, and beyond).
- Oversee the preparation and review of regulatory submissions (IND, NDA, BLA, MAA), as well as post approval activities.
- Drive collaboration with cross-functional teams, ensuring compliance and efficiency in drug development.
- Provide strategic guidance on CMC regulatory matters, shaping the regulatory landscape for the company’s pipeline.
- Represent the company in regulatory agency interactions, influencing outcomes in alignment with business goals.
Experience:
- Proven leadership experience in Regulatory CMC within the pharmaceutical industry.
- Expert knowledge of EMA and FDA regulatory requirements.
- Strong background in small molecule drug development.
- Exceptional communication and stakeholder management skills.
- Ability to drive innovation while ensuring regulatory compliance.
To apply, please contact me at rhi@greenlsr.com
Executive Director, Regulatory CMC employer: Green Life Science
Contact Detail:
Green Life Science Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Executive Director, Regulatory CMC
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in Regulatory CMC. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements of both the EMA and FDA. Understanding the nuances of these regulations can set you apart from other candidates and demonstrate your commitment to compliance and excellence in drug development.
✨Tip Number 3
Prepare to discuss your leadership style and how you've successfully driven cross-functional collaboration in previous roles. Be ready to provide examples of how you've influenced regulatory outcomes and fostered innovation while maintaining compliance.
✨Tip Number 4
Research the company’s pipeline and therapeutic areas they focus on. Tailoring your conversation to their specific projects and demonstrating your knowledge of their products will show your genuine interest and help you stand out during interviews.
We think you need these skills to ace Executive Director, Regulatory CMC
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Executive Director, Regulatory CMC position. Make sure you understand the key responsibilities and required qualifications, particularly the focus on small molecules and regulatory compliance.
Tailor Your CV: Customise your CV to highlight relevant experience in Regulatory CMC, especially your leadership roles and knowledge of EMA and FDA regulations. Use specific examples that demonstrate your expertise in small molecule drug development.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for leadership and innovation in the pharmaceutical industry. Address how your background aligns with the company's goals and your ability to drive regulatory strategies effectively.
Highlight Communication Skills: Emphasise your exceptional communication and stakeholder management skills in both your CV and cover letter. Provide examples of how you've successfully influenced outcomes in regulatory agency interactions.
How to prepare for a job interview at Green Life Science
✨Showcase Your Leadership Skills
As an Executive Director, your leadership experience is crucial. Be prepared to discuss specific examples of how you've led teams and driven strategy in previous roles, particularly in Regulatory CMC.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with the latest EMA and FDA regulations. During the interview, highlight your expertise in these areas and how it has influenced your past work, especially in small molecule drug development.
✨Prepare for Cross-Functional Collaboration Questions
Expect questions about your experience working with cross-functional teams. Prepare examples that illustrate your ability to foster collaboration and ensure compliance throughout the drug development process.
✨Influence and Communication Skills
Since you'll be representing the company in regulatory interactions, be ready to discuss how you've successfully influenced outcomes in the past. Highlight your communication strategies and stakeholder management skills.
