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Job Details

Regulatory Affairs CMC Lead (Global) - Switzerland, Belgium, UK

Company: Barrington James Clinical
Location: Europe
Reference: CRBG - CMCLEAD
Closing Date: 28 Jun 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

To take full ownership of the development and implementation of Regulatory CMC strategies covering the whole Bioloigcs product portfolio from development to pre/post approval and life cycle management.

Requirements:

Responsibilities:

  • Take responsibility for the line management and mentoring of the CMC Biologics team members providing RA CMC Support in late stage of development and post approval activities for the biologic products portfolio
  • Ensure the development of the CMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority interaction and influence)
  • Take ownership for the development and implementation of global and regional regulatory CMC strategies for assigned products
  • Managing the team resources efficiently – ensure proper resources allocation, enhance knowledge sharing and support the team to prioritize activities in line with PVU and GRA Practices objectives
  • Taking “Hands-on” accountability by managing CMC projects yourself
  • Developing and implementation of global and regional regulatory CMC strategies for assigned products
  • Taking over the accountability for all the team deliverables

Education/Skills Required: 

  • Educated to a Masters level, in a relevant life sciences or business related discipline
  • At least 10 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8 years of experience in Regulatory Affairs CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • Proven track record of successful leadership in delivering CMC sections of new marketing authorisations, clinical trial applications and post-approval submissions for biological and/or chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions on development and post-approval products
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC matters
  • Extensive active participation in regulatory agency meetings on CMC matters
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
  • Proven track in partnering with Health Authorities
  • Excellent interpersonal and leadership skills

Apply for this job: Regulatory Affairs CMC Lead (Global) - Switzerland, Belgium, UK

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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