2018-08-30

Head of Regulatory Affairs
Job Opportunity at Smart Staffing Svc. Inc. - BioTech

Posted on Aug 30

508-698-9988

Location: Cambridge, MA
Job Type: Full Time
Job ID: W4166974

Required Skills
  • Propose and design well-informed regulatory strategies for the US and EU
  • Represent Regulatory Affairs on project subteams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g., protocol reviews, report reviews, development plans)
  • Assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS)
  • Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages
  • Write regulatory documents to support regulatory submissions
  • Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
  • Coordinate with selected regulatory CROs for submission of high-quality documents to support Rest-of-World submissions
  • Establish and maintain ClinicalTrials.gov postings for supported studies
  • Establish relevant processes and procedures to support the Regulatory Affairs function activities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
  • Ensure compliance with regulatory requirements
     
Required Experience
  • Bachelor's degree in life sciences required; advanced degree preferred
  • Minimum of 8 years pharmaceutical industry experience with a minimum of 5 years in Regulatory Affairs
  • Experience with cell therapy products (preferably engineered adoptive cell therapies)
  • Evidence of successful submissions to FDA (e.g., INDs, briefing packages)
  • Demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans)
  • Knowledge of FDA and ICH regulations and guidelines a must
  • Knowledge of EU and Health Canada regulations and guidelines desirable
  • Knowledge of drug development
  • Excellent written and oral communication skills
  • Excellent interpersonal skills
  • Strong project management skills and drive for excellence
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