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Director/Senior Director Regulatory Affairs

  • Job type: Permanent
  • Location: Bedminster
  • Salary: $180000 - $200000 per annum
  • Job reference: MLSN112217138
  • Sector: EPM Scientific, Regulatory
  • Date posted: 22/11/2017
A global pharmaceutical leader that focusses on developing and manufacturing world-class innovative medicines are currently seeking a Director, Global Regulatory Lead as their company is expanding! This company has received recognition from their overall success and is looking to increase headcount. Now is a pivotal time to get in with this group as the Director, Global Regulatory Lead will have the ability to lead and impact important organizational changes.

 The Director, Global Regulatory Lead will have the following responsibilities:

 
The Director, Global Regulatory Lead will play a pivotal part for the company’s expansion and success.  They will work closely with key stakeholders and provide overall strategy for the department. They will oversee the team and be heavily involved in the regulatory strategy both internally and externally. They will also have experience reviewing regulatory submissions, FDA regulations, and being the company regulatory representative.
  • Serve as the Regulatory Affairs expert 
  • Work closely with the FDA and represent the regulatory team
  • Lead formulation of registration strategies
  • Mentor and guide junior RA team members
  • Work cross-functionally with various team 
The ideal candidate will have the following skill set:
  • Knowledge of  FDA regulations 
  • Experience in the pharmaceutical industry
  • Experience with ex-US regulatory authorities
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