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Job Details

Regulatory Scientist Part-Time Opportunity

Company: Roche
Location:
Reference: 3600175046
Closing Date: 26 May 18
Type: Full Time
Salary (£): On Application
Benefits:

Top Job

Job Summary:

Mark your mark and improve lives as Regulatory Scientist within our national (Local Operating Company) Regulatory Affairs team, part of our Licence to Operate (LTO) group along with Drug Safety and Quality, within the UK Medical Directorate. ...

Requirements:

Mark your mark and improve lives as Regulatory Scientist within our national (Local Operating Company) Regulatory Affairs team, part of our Licence to Operate (LTO) group along with Drug Safety and Quality, within the UK Medical Directorate.

 

A part-time opportunity (22 hours per week) has become available, responsible for the national regulatory management of assigned products nationally licenced in UK/IE/MT, UK CTAs, and the national regulatory aspects of Centralised Products managed by the Roche HQ team. You will also act as a subject matter expert for the Regulatory team in defined subject or process areas.

The key activities for a regulatory scientist are

  • Preparation and submission of high quality applications to maintain product compliance, or achieve clinical trials approval, collaborating cross-functionally
  • Ensuring that approved changes are implemented promptly and tracked
  • Timely communication of regulatory activities and timelines to support brand and clinical planning
  • Ensuring questions and commitments from our national regulatory authorities are proactively managed, and any issues are appropriately shared
  • Represent Regulatory Affairs as a primary product contact cross-functionally
  • Contribute to efficiency and process improvement through tracking tools and process documentation (SOPs, best practice guidance, templates)

 

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

This is an exciting time to join Roche Regulatory Affairs, with our industry-leading innovative portfolio of products, and as we prepare for the Regulatory changes consequential to Brexit.

 

We are looking for a University graduate, preferably in a scientific discipline, with experience in Regulatory Affairs and working knowledge of EU Regulatory procedures and UK/Ireland national guidance. You will have excellent attention to detail and accuracy, good communication skills, teamworking and IT ability. You are able to plan and manage complex activities.

 

Who we are

Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Apply for this job: Regulatory Scientist Part-Time Opportunity

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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