Accessibility Links

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
 

 

 


Similar jobs
Product Manager
  • Job type: Permanent
  • Location: Baden-Württemberg
  • Salary: Competitive
  • Description A leading Medical Device company is seeking a Product Manager Diagnostic Workflow Solution in Germany. The Product Manager will be responsible for assigned products and...
Product Manager - Ophthalmic Visualisation
  • Job type: Permanent
  • Location: Baden-Württemberg
  • Salary: Competitive
  • Description A leading Medical Device company is seeking a Product Manager Ophthalmic Visualisation in Germany. The Product Manager will cooperate with R&D to help design develop...
Product Manager - Diagnostic Workflow Solutions
  • Job type: Permanent
  • Location: Baden-Württemberg
  • Salary: Competitive
  • Description A leading Medical Device company is seeking a Product Manager Diagnostic Workflow Solution in Germany. The Product Manager will be responsible for assigned products and...
Sr. Director of Biostatistics
  • Job type: Permanent
  • Location: New Jersey
  • Salary: $180000 - $220000 per annum, Benefits: Comprehensive Bonus Package
  • Description Sr. Director of Biostatistics | FDA Experience Submission| Clinical trials I-IV | Various therapeutic areas   Greater New York
Clinical Data Manager
  • Job type: Permanent
  • Location: District of Columbia
  • Salary: Competitive
  • Description EDC | Phase I-IV Clinical Trials | Industry experience | Multiple locations  My client is an expanding Pharma company that is looking to add two CDMs to their...