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.