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For Companies At a Glance
- 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 with your expertise.
- Qualifications: Proven leadership in Regulatory CMC and expert knowledge of EMA and FDA requirements required.
- Other info: Contact rhi@greenlsr.com to apply and start your journey in a dynamic environment.
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
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 will not only enhance your knowledge but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your leadership experiences in detail. Think of specific examples where you successfully led cross-functional teams or influenced regulatory outcomes, as this will be crucial in showcasing your fit for the Executive Director role.
✨Tip Number 4
Stay updated on the latest developments in small molecule drug development. Being knowledgeable about current innovations and challenges in this area will help you stand out as a candidate who is not only experienced but also forward-thinking.
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, especially regarding EMA and FDA regulations.
Tailor Your CV: Customise your CV to highlight your leadership experience in Regulatory CMC and your expertise in small molecule drug development. Use specific examples that demonstrate your ability to drive strategy and ensure compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory excellence and innovation. Address how your background aligns with the company's goals and how you can contribute to their mission of delivering high-quality products.
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 Experience
As an Executive Director, your leadership skills are crucial. Be prepared to discuss specific examples of how you've led teams in Regulatory CMC, highlighting your ability to drive strategy and foster collaboration.
✨Demonstrate Regulatory Knowledge
Make sure you have a solid understanding of EMA and FDA regulations. Prepare to discuss how you've navigated these requirements in past roles, particularly in relation to small molecule drug development.
✨Prepare for Cross-Functional Collaboration Questions
Expect questions about your experience working with cross-functional teams. Think of examples where you've successfully collaborated with other departments to ensure compliance and efficiency in drug development.
✨Influence and Communication Skills
Since you'll be representing the company in regulatory agency interactions, be ready to discuss your communication strategies. Share instances where you've influenced outcomes in alignment with business goals, showcasing your stakeholder management skills.
