Regulatory Affairs Manager

Attribute Value
Type Full time
Salary Competitive
Closing date 30 June 2018
Reference RG130HP

A bit about us

Regulis is a specialist consultancy company providing global Regulatory Affairs, Pharmacovigilance and Quality Assurance services. The company was formed in 2001 and since then has seen significant growth.  The company is built around a growing permanent team based in Hertfordshire, UK, supplemented by an established global network of consultants to deliver high quality, customer-focussed solutions.

Our clients range from large multinationals to small start-up companies, from innovators to generic companies.

About the role

This position provides a stimulating, exciting and unique opportunity to the right person.  You will be managing a portfolio of clients and a range of projects working to often tight deadlines.  Working in our consultancy, you will be expected to apply your regulatory know-how and experience by working independently to take the lead on some of our more interesting and challenging projects.

The successful candidate will be expected to join the team and ‘hit the ground running’ with the medicine regulatory projects.  This could be your first step into a team management position so if that’s the case, we will provide help and guidance for you to grow into the role.

If you already have some supervisory/mentoring or management experience that’s good as you’ll have a foundation to build on.  You will also have the opportunity to play a part in helping to grow the business by attending client meetings and building strong relationships with new clients or maintaining relationships with existing clients.

The Regulatory Affairs team at Regulis is a dynamic and dedicated team that manages all aspects of a range of regulatory projects and assignments for medicinal products, biologicals, medical devices and drug-device combination products.

You will work directly with clients, managing projects with a significant degree of autonomy and independence, and interacting professionally at multiple levels within client organisations and with Agencies.

The position requires between 4-6 years’ experience in the medicines area of regulatory affairs.

Candidates will need to have broad experience of EU regulatory procedures including clinical trials and decentralised MAAs, ideally centralised procedures, scientific advice meetings and US NDAs.  Experience of biotechnology products would be useful but is not essential. Strong and demonstrable technical writing skills are a must and past experience with innovative development candidates would be ideal.

This is an excellent opportunity for a talented, independent and self-motivated regulatory professional to join a team that will not only provide you with a wide variety of experience in regulatory projects, it will also give you  the support you need to develop your regulatory career in the areas outlined above.

Key highlights

  • An opportunity to combine more complex regulatory project work and line management in one role
  • Forging strong relationships with clients and regulatory agencies
  • Being part of a small, high performing team
  • Taking responsibility for a wide range of national and regional regulatory applications.
  • The opportunity to play a part in growing and enhancing the strong reputation the company already has in the regulatory industry.

Your profile

  • Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
  • Between 4-6 years’ experience in the medicines area of regulatory affairs.

To succeed in this role you will require strong project management skills, excellent written and verbal communication skills, good organisational and analytical skills, a proactive approach, be able to work quickly and effectively under pressure, and be an outstanding team player. The successful candidate will also be fluent in written and spoken English.

What we offer

  • A competitive salary (depending on experience)
  • Benefits that include 25 days’ holiday, company pension scheme, life assurance, the option to buy or sell additional holiday, childcare vouchers, ‘fruity’ Tuesdays, an early finish on Fridays and an annual bonus and salary review.
  • Ongoing training and personal development support
  • The chance to be part of a TOPRA award winning consultancy that will help you to grow and build on your current experience aligning your career goals and aspirations with that of the company
  • A strong team ethic with regular events organised
  • Modern newly refurbished office in a town centre location with parking facilities.

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