Regulatory Affairs Director, Biologics

Director, Regulatory Biologics

Essential Pharma are looking for a Regulatory Biologics Director. This role is responsible for formulating and executing regulatory strategy for products, mainly within biologics, both in development and lifecycle management. It will have you leading and coordinating Regulatory Affairs activities cross functionally both in-house and through contractors. Apply today!

What You Will Do

Principal duties:

• Lead all aspects of Biologic Product regulatory activities as a subject matter expert
• Establish regulatory priorities and coordinate where required with Regulatory Affairs consultants, Quality, Manufacturing, Science & Technical (MSAT), Pharmacovigilance and Medical Affairs teams, to drive the effective submission, approval, and implementation processes for the product range.
• Lead regulatory activities of new biologic products acquisitions advising on transfer of Marketing Authorisations (MA) or lead the development of regulatory strategies and implementation plans for the preparation and submission of new products.
• Drive positive interactions with Regulatory authorities (e.g. MHRA, EMA, US FDA) to ensure smooth submission
• Oversee and execute high quality submissions, aligning with internal stakeholders.
• Operate internally and externally fulfilling the needs of the strategic regulatory and business goals of the company
• Lead the review of change controls from both internal and external sources in relation to the marketing authorisations and the marketing authorisation holders’ responsibilities. Prepare and own Change Request forms where required.
• Action, review and advise on the marketing authorisation holder communication with the competent authorities on regulatory and product specific matters. This includes but is not limited to regulatory applications, scientific advice/discussions and actions connected with product defects and recalls.
• Lead where required in the development and maintenance of standard operating procedures and local working practices
• Provide regulatory input to clinical trials and advise with respect to the MA applications that the trial will support.
• Drive Clinical trial registrations in applicable clinical sites (e.g. EU, UK, USA)
• Maintain current knowledge of relevant regulations related to Pharmaceutical Products, especially biologics, provide regulatory advice where required from Regulatory Affairs (including Regulatory consultants where required) and ensure the Regulatory and pharmacovigilance teams are informed and trained where necessary.
• Accountable for the delivery through others to: Ensure regulatory strategy is line with business goals for biologics.

What We Do

Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.

We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.

In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.

Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.

What You Will Bring

• Degree /Higher degree / professional qualification in Life Sciences
• 2-3 years as an Associate Director within Regulatory
• Significant experience of Regulatory Affairs within the European pharmaceutical industry and familiar with US regulatory affairs
• Prior experience in taking biologics through development to successful registration
• Experience in leading scientific advice for biological products
• Agile thinker who can adapt to situations of high-speed change
• In-depth knowledge of Regulatory Guidelines and EU/US legislation on biological products
• In-depth knowledge of the registration process and dossier structure and content
• In-depth knowledge of drug development, testing and manufacture

What We Offer

• Hybrid Working – we lead by our values of putting collaboration and dynamism at the centre of how we work. We offer flexibility and trust from day one.
• £150 towards your home office – claim purchases back on expenses.
• Healthcare Insurance
• Pension – you contribute 5% and we offer 3%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced Family Leave
• Enhanced Sick Pay
• Annual Leave – 26 days
• Discretionary Annual Performance Bonus

What To Expect

• We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
• Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
• Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.