Regulatory Affairs Senior Manager

Summary

Are you a seasoned regulatory professional ready to lead strategy and drive impact in the cutting-edge biotech sector? We’re partnered with an innovative pharma company in Grenoble that’s looking for a talented Regulatory Affairs Senior Manager to join their leadership team. This is an extraordinary opportunity to guide regulatory strategies and help bring life-changing therapies to market.

Everything you need to know about the role 

As the Regulatory Affairs Senior Manager, you’ll be at the forefront of developing and executing global regulatory strategies to support the company’s ambitious pipeline. You’ll provide expert guidance on regulatory submissions, compliance, and interactions with health authorities, ensuring that the company navigates the complex regulatory landscape efficiently and effectively.

• Lead Regulatory Affairs (RA) team for new product development in Pre-fillable Syringes (PFS) platform.

• Develop and implement regulatory strategies to ensure compliance with EU, FDA, and global standards.

• Guide cross-functional teams (R&D, Quality, Medical Affairs) on regulatory requirements, particularly design control.

• Manage regulatory submissions and interactions with Competent Authorities.

• Review promotional materials for regulatory alignment.

• Educate teams on evolving regulatory frameworks (EU, FDA, drug–device combination products).

Experience and qualities that make you a strong fit

• A degree in a relevant field such as life sciences, pharmacy, or a related discipline (advanced degrees preferred).
• 10+ years of regulatory affairs experience within the biotech or pharmaceutical industries, with a proven track record in global regulatory submissions and strategy.
• Deep understanding of U.S. and EU regulatory requirements, with experience in filings such as INDs, NDAs, and BLAs.
• Experience leading interactions with health authorities, including FDA meetings and advisory committees.
• Strong knowledge of ICH guidelines and other international regulatory frameworks.
• Exceptional leadership, project management, and communication skills.
• Proven ability to manage multiple priorities in a fast-paced, innovative environment.

What’s on offer?

• Regulatory Affairs within medical device/pharma, ideally with drug–device combination products.
• Previous roles as RA Specialist/Manager or R&D Manager.
• Proven track record with regulatory submissions and interactions with authorities.
• Deep understanding of U.S. medical device regulations, GCP, GLP, and QSR.
• Strong project management, negotiation, and communication skills.
• Team leadership/management experience (preferred).

Could this be the role for you?

If you’re ready to take on this exciting opportunity and bring your expertise to a company that’s shaping the future of healthcare, we’d love to hear from you. Please apply below or send your CV and a brief cover letter to [email protected]

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we’ll be more than happy to assist.