Global Head of Regulatory Affairs

Essential Pharma is looking for a Global Head of Regulatory Affairs to lead the regulatory team and provide oversight of all global regulatory activities. You will lead and develop regulatory strategies across all phases of product development and lifecycle management, ensuring compliance with global regulations. Apply Today!

What You Will Do

• Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.
• Partnering with the business as a strategic partner/advisor to help achieve company objectives including due diligence activities.
• Overseeing and contributing to the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others.
• Acting as the primary liaison with regulatory bodies, driving communications, and maximise the likelihood of timely approvals.
• Enhance cross-functional communication with in house and external partners to assure alignment with regulatory strategy.
• Lead and build the regulatory team to develop the knowledge, skills and capabilities to effectively deliver the business strategy. Build a culture of trust and communication so that the team can deliver to the best of their ability.
• Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
• Identifying potential regulatory risks and developing mitigation strategies.

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.

Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland.

What You Will Bring

• Extensive experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry ideally within a dynamic, fast-moving environment.
• Extensive knowledge of preparing and maintaining dossiers for clinical trials and marketing authorizations.
• Experience of seeking advice from and leading meetings with regulatory agencies including the FDA, EMA, and others.
• Experience of leading a growing team and partners across multiple countries and time zones. You will be adept at providing structure and clarity in a rapidly changing environment.
• Deep GxP knowledge.

What We Offer

• Salary – from £120,000
• Agile Working – we offer flexibility and trust from day one, it is typical to work 2 days a week at our Egham site.
• £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 plus bank holidays, 3 days shut down between Christmas and NY.
• Discretionary Annual Performance Bonus
• Recognition Program – from shout outs, vouchers and up to £2000 for gold awards!

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.