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Regulatory Affairs Senior Manager/ Associate Director- STRATEGY

  • Job type: Permanent
  • Location: Boston
  • Salary: $115000 - $150000 per annum
  • Job reference: fnmn752365
  • Sector: EPM Scientific, Regulatory
  • Date posted: 25/08/2017
Regulatory Affairs Senior Manager/ Associate Director- STRATEGY  needed for a Global Pharmaceutical Company!
  • Global Regulatory Affairs Experience
  • NDA/BLA/MAA submissions in US and/or EU
  • Phase II-III
  • Oncology Experience preferred
 

Manager/AD level | Regulatory Affairs | Oncology


Location: Boston, MA


Salary: $115,000-$150,000 + bonus + excellent benefits


This biopharmaceutical company set in the Greater Boston Area is working on a number of products within the Oncology space. Their mission is to bring less toxic; more effective therapies to market that will treat and even cure these diseases. 


Key Responsibilities Include:
  • Serve as Global indication team lead on the *** Program
  • Lead the RST and obtain input from Global Regulatory Affairs RST stakeholders
  • Define the transition plan to Marketed Product Lead (MPL)
  • Effective timeline management
  • Accountable for the strategy related to and operational excellence in the delivery of CTA / IND / ODD / PIP / SA / BB / MAA / NDA
The Ideal Candidate Will:

Internally: 
  • Good organizational and planning skills
  • Ability to lead and work in teams
  • Ability to communicate with cross functional teams and operation staff
PROFESSIONAL SKILLS & EXPERIENCE
  • Bachelors degree required, advanced degree preferred in related scientific field
  • Minimum 8 years industry experience with 6 years serving in a global regulatory function
  • Experience with the clinical trial phase of development, e.g. IND/CTA requirements
 

 

 


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