Director of Regulatory Affairs
Company: Kelaca
- Location: London, United Kingdom
- Work mode: Hybrid
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Regulatory Affairs Director
London (hybrid, 3 to 4 days in the office)
£120,000 to £150,000 + benefits
I’m working on a confidential leadership hire for an established early phase CRO in London. Their work centres on first-in-human and early clinical studies for biotech and pharma sponsors, across a broad range of modalities.
This is a regulatory leadership role for a medically qualified professional with hands-on experience of clinical trial applications for medicinal products, from the regulator side as a medical or clinical assessor.
What you’ll do
- Advise sponsors on the regulatory route into the clinic, including CTA and IND strategy, IMPD and IB content, and scientific advice
- Act as the lead contact for regulators on behalf of the business
- Lead a team covering regulatory, scientific writing and drug safety
- Join sponsor and new business conversations as the senior regulatory voice
What you need
- Medical degree and GMC registration
- Experience as a medical or clinical assessor at the MHRA or an equivalent agency
- Direct experience assessing, authoring or leading CTAs or INDs for medicinal products
- 8+ years in drug development across a regulator and pharma, a CRO or a regulatory consultancy
- Experience line managing a team
- A solid grasp of early phase trial design
You’ll lead the drug safety team, but deep pharmacovigilance systems expertise isn’t required, as there’s an established safety function in place.
Please note this role requires regulatory experience with medicinal products. Experience limited to medical devices, IVDs, CQC or clinical governance won’t be sufficient.
Why consider it
A senior role where regulatory judgement shapes programmes from the very start, with a team to lead and a seat in conversations with sponsors.
Conversations are fully confidential and the client is shared after an initial call. Message me directly or apply here.
