- Lead regulatory activities for drug-device combination products from clinical development through to NDA/MAA submissions.
- Manage the preparation and delivery of regulatory dossiers, ensuring critical timelines are met.
- Support US NDA submissions, including Device Master File (DMF) activities for combination products.
- Provide regulatory expertise in medical devices, including design control and risk management.
- Collaborate with cross-functional teams to drive successful regulatory outcomes.
Main Requirements
- Proven end-to-end Regulatory Affairs experience from IND/CTA through to NDA and/or MAA submissions.
- Strong drug-device combination product experience, including DMF submissions.
- Recent medical device regulatory expertise and knowledge of current device regulations.
- Experience supporting US NDA submissions.
- Strong project management skills with a track record of delivering complex submissions to tight deadlines.
- Sponsor-side experience within pharmaceutical, biotech, or combination product companies.
- Inhalation drug-device combination product experience is highly desirable.
- Able to work independently and hit the ground running in a fast-paced environment.
We are an equal opportunities Recruitment Business and Age ncy. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
#J-18808-Ljbffr
Regulatory Affairs Consultant in London employer: Planet Pharma
Join a leading biopharmaceutical organisation in Slough, where innovation meets collaboration. As a Scientist in Antibody Formulation Development, you'll thrive in a dynamic work culture that prioritises employee growth and offers unique opportunities to contribute to groundbreaking research. With a focus on professional development and a supportive team environment, this role promises a rewarding experience for those passionate about advancing biopharma solutions.
