Regulatory Affairs Project Manager/Senior Regulatory Affairs Executive

Attribute Value
Type Full time
Salary Competitive
Closing date 31 March 2018
Reference RG126HP

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 Tring, 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

Regulis Consulting is offering a unique and exciting opportunity for you to join a dynamic and dedicated team. Within the Regulatory Affairs team you will manage all aspects of a range of regulatory projects and assignments for medicinal products, biologicals 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 3-5 years’ experience in the medicines area of regulatory affairs. The role will also allow the right candidate to work with the Managing Director to grow the business by identifying opportunities with new and existing clients and participate in bid defence meetings.

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.  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 all the support you need to develop your regulatory career.

Key highlights

  • A rare opportunity to combine regulatory project work and business development activities 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
  • Between 3-5 years’ experience in the medicines area of regulatory affairs

To succeed in this role you will require excellent written and verbal communication skills, good organisational and analytical skills, a proactive approach, be able to work quickly and effectively 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, pension, life assurance, option to buy or sell additional holiday, childcare vouchers and annual bonus
  • 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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