Regulatroy Affairs Manager

Highly Competitive
  1. Contract
  2. Project Manager, CMC
  3. United Kingdom
Cambridge, England
Posting date: 10 Sep 2019

Proclinical Staffing is currently recruiting for a Regulatory Affairs Manager job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in Cambridge. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.

Job Responsibilities:

  • Leading regulatory projects for emerging markets commercialisation and life cycle management of assigned products.
  • Developing regional strategy and execution of the preparation of CMC components of filings for one or more products.
  • Organising and preparing CMC investigational product amendments and post-market supplements, organising and preparing CMC sections of annual reports (Canada Annual Notification, Brazil HMP), GMP registration of facilities.
  • Providing guidance on regional regulatory mechanisms to optimize product registration, including expertise on regional regulatory requirements and precedence to cross functional teams.

Skills and Requirements:

  • Biologics experience is ideal, with small molecule experience also accepted.
  • LATAM, Canada, South Africa, and Middle East regional experience is needed.
  • 5 years + exp in regulatory pharma.
  • Immediate starters preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website -

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.