Regulatory Affairs Consultant

• 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.www.planet-pharma.com

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