Regulatory Policy and Project Manager

£60 - £65 per hour
  1. Interim/Contract
Uxbridge, London
  1. Regulatory Affairs, Operations
Posted: 11/03/2020
BBBH13647

This vacancy has now expired. Please see similar roles below...

Hobson Prior are looking for a Regulatory Policy and Project Manager for an exciting opportunity to join a top pharmaceutical organisation who are focused on improving the lives of patients all over the world. You will join them on a contract basis in Uxbridge.

Job Responsibilities:

  • Lead projects and policy initiatives and supports the organisation's affiliate regulatory team to predict and plan regulatory policy solutions to achieve operational excellence.
  • Support the organisation's affiliate regulatory team to achieve clarity on issues (e.g. Brexit), and develop strategies to plan for and mitigate challenges - project manage the organisations Brexit execution.
  • Interface with UK/Ireland affiliate regulatory senior manager and advise/support decision-making and developing strategies for Brexit - implement the right local regulatory frameworks, plans and processes to ensure readiness for a possible "hard Brexit".
  • Working in partnership with the Senior Regulatory Affairs Manager will execute the UK/Ireland Brexit regulatory strategy
  • Key responsibility for monitoring legislation, guidelines and the UK and Ireland national regulatory environment to maintain company intelligence and awareness, for compliance and best practice, within the UK/Ireland affiliate.
  • Quality-facing - Interfaces with the UK/Ireland affiliate quality team to ensure UK/Ireland RA team function in compliance with all GxP related activities.
  • Supports with all regulatory activities on local level (UK/Ireland Affiliate).
  • Co-operates cross functionally with the company's affiliate BU/International/Europe on local regulatory activities for assigned projects.
  • Communicates efficiently and effectively with the relevant National Authorities (UK/Ireland).
  • Drives and ensures regulatory compliance with local legislation.
  • Acts as the UK/Ireland Affiliate Policy, Procedures and Intelligence Lead.

Key Skills:

  • Strong interpersonal skills and demonstrable, cross functional collaborative work experience.
  • Be a team player and be willing to work in an environment where individual initiative, flexibility and accountability to the team are required.
  • A good understanding of internal customer needs and project needs as well as a commercial awareness.
  • A strong, demonstrable, commitment to regulatory compliance.
  • Able to multi task whilst maintaining a very high level of accuracy and attention to detail.

Requirements:

  • Minimum BSc Life science/pharmacy degree essential.
  • Good working knowledge of UK/Ireland local regulatory requirements in the pharmaceutical industry including the relevant sections of the EU regulation, EU clinical trials directive and ICH guidelines.
  • Must have extensive UK and/or UK/Ireland regulatory affiliate experience within a pharmaceutical company (ideally involving broad & varied UK/Ireland affiliate regulatory strategy, policy and project management activities).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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