Director, Principal Consultant Regulatory Affairs CMC

    Woburn, Massachusetts (USA), US
One Presidential Way
01801 Woburn, Massachusetts (USA)
Vereinigte Staaten


 

Director, Principal Consultant Regulatory Affairs CMC

Location: UK, Spain, US
Possibility to work remotely


Job purpose

  • Develop new CMC large volume services approaches through market and competitor analysis and client need analysis 
  • Define appropriate processes within global REG CMC to support large volume and complex programs of PharmaLex
  • Responsible to write PharmaLex CMC proposals with special focus on large and complex program proposals in close collaboration with the Heads of REG Service Areas Business Development, Program Management and Regional Management and other VDCs (Value Delivery Centers)
  • Represent CMC in complex and strategic bid defense meetings and client interactions
  • Responsibility as Deputy of Head of Global Regulatory CMC
  • Support the Head of Global Regulatory CMC and the REG Service Areas Business Development, Program Management and Regional Management in definition of regulations and processes within CMC globally as requested

Your profile
 
  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
  • University degree natural sciences, ideally with PhD.
  • Several years of experience and broad knowledge in the field of Regulatory CMC
  • Several years of experience in identifying needs in CMC and related areas / interface functions of a pharmaceutical company, either from a service provider perspective or from a cross-departmental company internal perspective
  • Knowledge of and experience in regulatory processes, responsibilities and needs in multinational pharmaceutical companies
  • Several years of experience in a leadership or a project management role
  • Experience in defining and implementation of new services, strategies and processes
  • Ideally expertise on market research and service development
  • Knowledge in contracting and negotiating.
  • Very good ability to analyse and solve problems and to develop possible solutions.
  • Ability to professionally represent the company both externally and internally.
  • Professional written and verbal communication skills (English).
  • Resilience, willingness to work a flexible schedule and travel.



If you are interested in joining our Pharmalex team taking over this challenging job opportunity we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
 

Agencies only by prior agreement for the specific job opportunity.

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