Global Head of Regulatory Affairs

Essential Pharma are looking for a Global Head of Regulatory Affairs. You will be responsible for leading a small team, developing and implementing regulatory strategies, interfacing with our partners and regulatory agencies. We are looking for deep GxP knowledge, an excellent leader and relationship builder. Apply Today!What You Will DoDevelop and implement regulatory strategies, managing local regulatory partners and ensuring appropriate data management systems are in place. Leading the creation and execution of regulatory plans across global markets to ensure compliance with local and international regulations. Regulatory submissions: overseeing the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others. Cross-functional leadership: leading and coordinating with both in-house and external teams to ensure alignment on regulatory requirements. Agency interactions: acting as the primary liaison with regulatory bodies, managing communications, and ensuring timely approvals. Compliance monitoring: staying updated on global regulatory changes and ensuring that products remain compliant throughout their lifecycle. Risk management: identifying potential regulatory risks and developing mitigation strategies. Training and mentorship: leading and mentoring the regulatory affairs teams, fostering expertise in regulatory matters within the organization. What We DoEssential 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 BringExtensive experience in regulatory affairs within the pharmaceutical, biotech, medical device industry, including global markets (e.g., US, EU, ROW). In-depth understanding of regulatory requirements and guidelines from agencies like the FDA, EMA, and others. Extensive experience of leading small teams across multiple countries and time zones. Deep GxP knowledge. What We OfferSalary – from £120,000Agile Working – we offer flexibility and trust from day one, when you attend the office will be guided by business needs and role requirements. This role requires you to work a least one day per week from our Egham, Surrey office with flexibility for business needs and company events.£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 ExpectWe 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.