Sr Mang/A.D. Reg. Affairs - with a Biotech company

  • inVentiv
  • Cambridge, MA, United States
  • Jun 15, 2017
Full time Regulatory

Job Description

Order #: 102503

Title of Position: PERM Sr. Manager/A.D. Reg Affairs

Location: Cambridge, MA  

Senior Manager/Associate Director, Regulatory Affairs

 

This position will serve as the global regulatory lead for assigned programs. This role requires expert interpretation of requirements relating to the development and licensing of biopharmaceuticals and communication to cross-functional teams to create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, the RA Senior Manager will represent the team before health authorities. In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions