Associate Director Regulatory Affairs

3 weeks ago

Egham Surrey, United Kingdom Essential Pharma Full time

Essential Pharma are looking for an Associate Director to bring deep knowledge of biologics products to manage the global regulatory aspects of this exciting, growing portfolio area. Apply Today

What You Will Do

  • Reporting into the RP, Senior Director you will lead your own regulatory projects with a focus on biologic products, either in the rare disease or other indications, working to strict deadlines.
  • Action and coordinate regulatory affairs activities both in-house and through our partners.
  • Provide regulatory expertise to technical projects, ensure compliance at contract manufacturing sites is maintained and the development of product information including product artwork is delivered.
  • Lead on support for both acquisition and integration of new products into the portfolio and organic growth of the existing portfolio.
  • Work with a range of stakeholders including the broader regulatory team and PV to resolve issues, manage regulatory processes and ensure your knowledge of relevant regulations, especially as it relates to biologic pharmaceutical products, is shared to ensure we are developing knowledge across the business.

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

  • Sciences degree coupled with a professional qualification e.g. a registered pharmacist.
  • Deep knowledge of global regulatory affairs working with biologic pharmaceutical products, US markets experience is particularly relevant.
  • Eligibility to live and work in the UK.

What We Offer

  • Agile 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

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