Senior Director Regulatory Affairs

1 week ago

Egham Surrey, United Kingdom Essential Pharma Full time €120,000

Essential Pharma is looking for a Senior Director to lead the regulatory team (8) and provide oversight of all global regulatory activities. You will report into the VP for Portfolio Optimization, developing regulatory strategies across all phases of product development and lifecycle management, ensuring compliance with global regulations. Essential have over 300 MAs, a broad portfolio of small molecule established medicines coupled with an emerging biologics portfolio. 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.

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

  • Extensive generalist 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 MHRA, EMA. It would be desirable to have a strong knowledge of working with the FDA.
  • Experience of leading a growing team and partners across multiple countries and time zones.
  • 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, Surrey 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.
  • 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.

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