Regulatory Affairs Manager

Location
Hertfordshire
Salary
On Application
Posted
27 Nov 2018
Closes
27 Dec 2018
Ref
RAManager
Contract Type
Permanent

This position will see the right candidate working alongside the senior management team, in a supportive environment where you can have a real impact on the company and its growth. In addition to the fantastic professional experience this role offers, the client is also offering a multitude of benefits including a company healthcare scheme and a contributory pension scheme.

Regulatory Affairs Manager – Hertfordshire

Job Responsibilities

  • Support the preparation and submission of Marketing Authorisations (MA) applications, post-approval, variations, renewals, and post-marketing commitment submissions
  • Assess the viability of entering new markets, taking into consideration the requirements, timelines and conditions, with the help of the commercial department
  • Review artwork and labeling changes, which would encompass third-party artwork house
  • Liaise effectively with clients and partners externally, with partner’s regulatory teams
  • Seek advice and guidance from regulatory authorities to resolve any arising issues
  • Monitor the relevant electronic systems and ensure they are all updated and maintained in alignment with regulatory submissions and commitments

Key Skills

  • Ability to project manage and prioritise workload
  • Attention to detail
  • Can sustain a positive can-do attitude, even when faced with larger issues
  • Proficient in Microsoft Excel and Microsoft Word

Requirements

  • Bachelor’s degree equivalent or higher qualification within life sciences
  • Knowledge of MHRA regulations
  • Strong knowledge of DCP / National and lifecycle maintenance
  • Hands-on experience of MA transfers
  • Authoring and preparation of regulatory packages and documents for submission

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 specialist life science 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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