Head of Regulatory Affairs in Oxfordshire

Job description

I’m partnering with a growing Biotech company that’s focused on developing innovative health therapeutics to improve patient outcomes. Currently at the preclinical stage, they are looking for a Head of Regulatory Affairs to lead their regulatory strategy and guide the business through the next stages of development.

Key Responsibilities:

• Lead regulatory strategy for preclinical and clinical development.
• Manage submissions and interactions with MHRA, EMA, and FDA.
• Ensure compliance with regulatory requirements across drug development.
• Collaborate with cross-functional teams to align regulatory goals with project milestones.
• Prepare and review high-quality regulatory documents.
• Advise leadership on regulatory risks and opportunities.
• Represent the company in discussions with regulatory authorities.

Key Requirements:

• Advanced degree (MSc, PhD, PharmD, or equivalent) in life sciences, pharmacy, or medicine.
• Strong experience in regulatory affairs within biotech or pharma.
• Proven track record leading regulatory strategies, submissions, and authority interactions.
• Solid understanding of regulatory requirements across preclinical, clinical, and CMC stages.
• Experience working with MHRA, EMA, and FDA.
• Ability to lead cross-functional teams and projects with strategic impact.
• Excellent communication skills, both written and verbal.

Extra information

Status

Open

Education Level

Secondary School

Location

Oxfordshire

Type of Contract

Part-time jobs

Published at

21-10-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English