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Associate Director of Regulatory Affairs

  • Job type: Permanent
  • Location: Frankfurt am Main
  • Salary: Competitive
  • Job reference: Ass Director of Reg
  • Sector: EPM Scientific, Regulatory
  • Date posted: 03/11/2017
Associate Director of Regulatory Affairs

The Company

My Client is the world leader in developing and marketing both biopharmaceutical and small molecule drugs that provide meaningful advances to patients who live with serious and life – threatening diseases. In 2017, they are rapidly expanding and their current site in Frankfurt has the potential to grow into a more global and senior position within the next few years.


 


The Role

Associate Director of Regulatory Affairs

Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development. Serve as the Regulatory Affairs representative on project teams or any relevant team; assure the progress of projects by providing direction, solutions and feedback to the teams. Lead regulatory interactions with health authorities, manage document preparation, coordination rehearsals and minutes. Manage meetings with marketing partners, and vendors for their products/projects. Support the company's commercial products. Review and approve labelling for the company's products. Review of protocols, Investigator Brochures, IND/IMPDs, reports and all types of regulatory documentation (quality, safety, efficacy and labelling) including CTAs.




Job Requirements

  • Established Regulatory Management Background
  • Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
  • Demonstrated leadership success in management of regulatory activities
  • Excellent verbal and written English and communication skills
  • Experience with supporting a project with development activities in at least two regions
  • Knowledge of international (WW) regulatory affairs (demonstrated by above)
  • BSc or MSc in Pharmaceuticals/Biochemistry/Biomedical
 


 


If this a position you are interested in, please submit a copy of your most up-to-date CV in Microsoft Word format to;



apply.a33ho1gjl59@epmscientific.aptrack.co.uk



Or Call;


+0044 203 758 8784


 Nicky Walsh


Head of Quality Management for EPM Scientific, Frankfurt


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