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Sr. Manager, Regulatory Affairs

Cambridge, Massachusetts

Post Date: 07/24/2017 Job ID: 1355 Job Category: Clinical: Regulatory

My client is seeking a Senior Manager, Regulatory Affairs to 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 R&D team before health authorities. 

Job Responsibilities:
  • Responsible for developing innovative global regulatory strategies for assigned programs and working with the regulatory team on execution.
  • Represents regulatory affairs on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
  • Responsible for maintaining and updating the regulatory strategy document and target product profile for assigned programs.
  • Interacts directly with health authorities and responsible for the compilation, submission, and maintenance of all clinical trial applications and marketing authorizations.
  • Adept at integrating biomarker/companion diagnostic strategies into the development of assigned programs.
  • Educates company on regulatory requirements and evolving trends and disseminates regulatory intelligence relevant to the business.
  • Provides regulatory due diligence assessments of new business opportunities.
  • Contributes to the hiring and development of team members to become leaders.

Qualifications/ Requirements:
  • Bachelor’ s degree in a scientific or health-related field (advanced degree highly preferred)
  • Minimum of 7 years of regulatory affairs experience in the biopharmaceutical industry
  • Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for assigned programs
  • Experience with development of biomarkers and IVD companion diagnostics devices preferred
  • 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
  • Strategic thinker with excellent problem solving and influencing skills
  • Exceptional communication and presentation skills to ensure the regulatory strategy is clearly articulated in cross-functional teams
  • Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities
  • Track record of building an excellent relationship with the FDA and other regulatory agencies

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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