Senior Regulatory Affairs Executive – Medicines

Attribute Value
Type Full time
Salary Competitive
Closing date 31 October 2020
Reference RG138HP

A bit about us

Regulis is a specialist consultancy company, formed in 2001, providing global Regulatory Affairs, Pharmacovigilance and Quality Assurance services. The company is built around a growing permanent team based in Tring, Hertfordshire, UK supplemented by an established network of consultants to deliver high quality, customer-focussed solutions.  This is a very exciting time to be joining us because in June 2020, Regulis merged with PharmaLex, a leading consultancy company with offices located globally.

Our clients include large, medium and small pharmaceutical companies located across the world.

About the role

This is an exciting opportunity to join a dynamic and dedicated team at Regulis.  Within the Regulatory Affairs team you will be responsible for providing regulatory expertise in the development, registration and post-approval activities of medicines and ensuring high quality and timely delivery of consulting services to our clients.

You will work directly with clients, handling tasks with minimum supervision and interacting professionally at multiple levels within client organisations.

The position requires at least 3-4 years of experience in the medicines field of regulatory affairs.  You will have good technical writing skills and be confident in preparing regulatory documents.  The role will allow the right candidate to gain experience with medicinal product development through to post licencing regulatory activities.

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

  • Exposure to a wide variety of regulatory projects providing strategic advice to optimise regulatory pathways for clients
  • Supporting the preparation of regulatory documentation including ODD, PRIME, CTA, Ethics and MA applications
  • Providing support to clients in technical dossier requirements and compiling modules of the CTD for various product developments
  • Forging strong relationships with clients and regulatory agencies through scientific advice meetings and agency negotiations
  • Being part of a small, high performing team, you will be involved in mentoring other team members on key projects
  • 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
  • At least 3-4 years’ experience in the medicines industry
  • Experience in writing EU regulatory documents with sound knowledge of the EU medicines Directive associated guidelines
  • Proven capability in working on multiple projects and effectively managing time to meeting critical timelines
  • Able to demonstrate effective communication skills in dealing with diverse group of stakeholders
  • A willingness to support resolving complex issues and driven to deliver results
  • Good organisational and analytical skills with the flexibility to work across multiple client projects, with excellent attention to detail

You will be expected to work independently on a day-to-day basis, whilst integrating into team project work.  A proactive approach with a hands on, can do attitude required for a small team.  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, fresh fruit delivered weekly in the office, opportunity to work flexibly with some home working*, 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*.

*The role will initially be home-based due to current Covid restrictions.  The successful candidate would be required to live within commuting distance of our office in Tring, Hertfordshire.

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