Director of Regulatory Affairs

Blackfield associates are continuing our support for an innovative expanded access pharma company with a new Biologics project. We’re looking for an experienced Regulatory Director to join their Greater London based UK office.

As Regulatory Affairs Director, you will have the following responsibilities:

Regulatory Leadership & Strategy

• Lead all aspects of Biologic Product Regulatory activities as a subject matter expert.
• Establish regulatory priorities and coordinate with Regulatory Affairs consultants, Quality, Manufacturing, Science & Technical (MSAT), Pharmacovigilance, and Medical Affairs teams to drive effective submission, approval, and implementation processes for the product range.
• Ensure regulatory strategy aligns with business goals for biologics.

Regulatory Submissions & Compliance

• Oversee and execute high-quality regulatory submissions, ensuring alignment with internal stakeholders.
• Drive positive interactions with Regulatory Authorities (e.g. MHRA, EMA, US FDA) to facilitate smooth submission processes.
• Action, review, and advise on marketing authorisation holder (MAH) communication with competent authorities on regulatory and product-specific matters, including applications, scientific advice, product defects, and recalls

Product Development & Change Controls

• Lead regulatory activities for new biologic product acquisitions, advising on Marketing Authorisation (MA) transfers or developing regulatory strategies for new product submissions.
• Lead the review of change controls from both internal and external sources related to marketing authorisations and MAH responsibilities.

Clinical & Pharmacovigilance Support

• Operate both internally and externally to fulfill strategic regulatory and business goals.
• Accountable for regulatory delivery through others, ensuring regulatory strategy aligns with overall business objectives.

To be considered for the role of Regulatory Director, you will have:

• Educated to Degree level in related Life science disciplines
• Extensive, hands-on experience with EU regulatory requires, ideally strong Knowle or familiar with US requirements
• Must have proven background in Biologics, either developing strategy and implementation or taking projects from development to successful registration
• Previous experience in higher level role such as Associate Director or Senior Lead- with direct line management experience
• Held/ chaired Scientific advise meetings
• Minimum 10 years’ experience, gained in pharmaceutical drug development

This is a hybrid working role, with no ability to sponsor. Applicants must hold valid right to work in the UK, and able to commute weekly to our clients office.