Regulatory Lead...

Job Description

Regulatory Lead

Essential Pharma are looking for a 2 Regulatory Leads, 1 will cover the Ophthalmology and CNS therapeutic area and the other will cover the Infectious Disease and Internal Medicine therapeutic areas. The Regulatory Lead ensures compliance with regional and global regulatory requirements for existing and newly acquired products, develops and implements regulatory strategies, leads interactions with regulatory agencies and manages a regulatory team. Drives strategic planning based on European and UK regulatory guidelines in each therapeutic area. Apply today!

What You Will Do

• Develop and implement regional and global regulatory strategies for established products
  
• Lead and manage interactions with regulatory authorities
  
• Work with commercial, MSAT, CMC, Supply Chain, Medical Affairs and Pharmacovigilance
  
• Ensure compliance by adhering to internal processes and external regional regulatory requirements
  
• Monitor and address regulatory changes in global markets and share knowledge
  
• Lead and coach Regulatory Professionals: make feedback to develop team members, define clear objectives for the team in alignment with company goals, make responsible decisions to drive performance
  
  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
  
  
• Advanced degree in life sciences
  
• In depth knowledge of European, and ROW regulatory environment, particularly CMC requirements
  
• Regulatory expertise of developing and maintaining any of the following: Central Nervous System, Ophthalmology, Internal Medicine or Infectious Disease drugs in EU and UK
  
  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 5%.
  
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
  
• Enhanced Family Leave
  
• Enhanced Sick Pay
  
• 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.