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- Tasks: Lead a team to ensure compliance with global regulatory requirements for biotech products.
- Company: Join a pioneering European biotech firm focused on innovative therapeutics for rare diseases.
- Benefits: Enjoy remote work flexibility and the chance to travel to HQ.
- Why this job: Make a real impact in patients' lives while working in a dynamic, supportive environment.
- Qualifications: 10+ years in Regulatory CMC, team leadership, and knowledge of US/EU regulations required.
- Other info: Passion for rare disease treatments is essential.
The predicted salary is between 72000 - 108000 £ per year.
Head of Regulatory Affairs CMC Location: Remote in Europe (with travel to HQ required) About the job We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which have now been launched in markets around the world. The portfolio now ranges from preclinical to approved products, with multiple new indications currently being explored. This role is an exciting opportunity to join as Head of Regulatory Affairs CMC. Reporting directly to the Global Head of Regulatory, you will play a pivotal role in ensuring compliance with global regulatory requirements while facilitating product approval and lifecycle management. You will lead a team of approx. 20 individuals, providing them with direction, coaching & motivation. We are looking for candidates who have the below experience: Over 10 years’ experience in Regulatory CMC from the biopharma industry and expertise in biologics or antibody would be an advantage Orphan drugs experience would be desirable Team leadership experience is a must of this candidate, with strong experience in coaching and developing regulatory teams In depth knowledge of global regulatory CMC requirements, particularly within US and EU markets A clear passion & motivation for bringing rare disease treatments to patients with unmet medical need Please apply with an up to date CV for consideration.
Head of Regulatory Affairs CMC employer: CT19
Contact Detail:
CT19 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs CMC
✨Tip Number 1
Make sure to highlight your extensive experience in Regulatory CMC, especially within the biopharma industry. Tailor your discussions to showcase specific projects where you successfully navigated complex regulatory landscapes.
✨Tip Number 2
Demonstrate your leadership skills by sharing examples of how you've coached and developed teams in previous roles. This will show us that you can effectively lead a team of approximately 20 individuals.
✨Tip Number 3
Familiarize yourself with the latest trends and regulations in both the US and EU markets. Being well-versed in current global regulatory CMC requirements will set you apart as a candidate who is ready to hit the ground running.
✨Tip Number 4
Express your passion for rare disease treatments during your conversations with us. Sharing personal motivations or experiences related to this field can resonate well and demonstrate your commitment to making a difference.
We think you need these skills to ace Head of Regulatory Affairs CMC
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your over 10 years of experience in Regulatory CMC within the biopharma industry. Detail your expertise in biologics or antibodies, and if applicable, mention any experience with orphan drugs.
Showcase Leadership Skills: Since team leadership experience is crucial for this role, provide specific examples of how you have successfully coached and developed regulatory teams in the past. Highlight your ability to motivate and direct a team effectively.
Demonstrate Regulatory Knowledge: Clearly outline your in-depth knowledge of global regulatory CMC requirements, particularly focusing on US and EU markets. This will show that you are well-prepared for the compliance aspects of the role.
Express Passion for Rare Diseases: Convey your passion and motivation for bringing treatments to patients with unmet medical needs. This personal touch can make your application stand out and resonate with the company's mission.
How to prepare for a job interview at CT19
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in Regulatory CMC, especially within the biopharma industry. Be prepared to discuss specific examples of how you've navigated complex regulatory landscapes and achieved successful product approvals.
✨Demonstrate Leadership Skills
Since this role involves leading a team, emphasize your leadership experience. Share stories about how you've coached and developed teams, and how you foster a collaborative environment that drives results.
✨Passion for Rare Diseases
Express your genuine passion for working on treatments for rare diseases. Discuss any relevant experiences or motivations that drive your commitment to improving patient outcomes in this area.
✨Prepare for Global Regulatory Discussions
Given the global nature of the role, be ready to discuss your knowledge of regulatory requirements in both the US and EU markets. Familiarize yourself with recent changes in regulations that could impact CMC processes.
