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Global Head of Regulatory Affairs

2 months ago

Egham, Surrey, United Kingdom Essential Pharma Full time
Job Title: Global Head of Regulatory Affairs

Essential Pharma is seeking a highly experienced Global Head of Regulatory Affairs to lead our regulatory affairs team. As a key member of our leadership team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with local and international regulations.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Lead the creation and execution of regulatory plans across global markets.
  • Oversee the preparation, submission, and management of regulatory documents to health authorities.
  • Lead cross-functional teams to ensure alignment on regulatory requirements.
  • Act as the primary liaison with regulatory bodies and manage communications.
  • Monitor global regulatory changes and ensure compliance throughout the product lifecycle.
  • Identify potential regulatory risks and develop mitigation strategies.
  • Lead and mentor the regulatory affairs team to foster expertise in regulatory matters.
About Essential Pharma:

We are 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.

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 group's second product for treatment of a rare disease, and the first development-stage asset in our portfolio.

What We Offer:
  • Salary: £120,000
  • Agile Working: flexibility and trust from day one
  • £150 towards your home office
  • Healthcare Insurance
  • Pension: 5% employee contribution and 3% employer contribution
  • 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
Company Culture:

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.