Planet Pharma
Regulatory Affairs Consultant
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Position: Regulatory Affairs Consultant
Location: UK - Hybrid in London
Client: Biotechnology
Type: 12 months Contract, Full-time
Main Responsibilities
- 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.
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ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
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Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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