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Director, Regulatory Affairs

  • Location: Parsippany-Troy Hills Township
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 25 days ago

Job Description

Responsibilities

  • Provides regulatory leadership, and develop global regulatory and clinical strategies for assigned development projects or marketed products.
  • Provide strategic input and regulatory advice to the project teams on development programs.
  • Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
  • Provide oversight of regulatory timelines and track deliverables
  • Interface with functional areas to identify and obtain information required for regulatory submissions
  • Develop and/or review regulatory documents to ensure that all submissions are of high quality
  • Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments and NDA/BLA/MAA
  • Lead the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA).
  • Provide regulatory oversight of maintenance submissions (DSUR, PSUR, Annual Reports, etc) of assigned projects in multiple countries
  • Interface with global regulatory authorities and consultants as needed
  • Lead the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications
  • Lead the preparation of responses to questions from Regulatory Authorities

Qualifications

  • Minimum Master's degree in Pharmacy, Biology, Chemistry or related healthcare functional area. Advanced degree (PhD, MD or Pharm D) preferred.
  • Strong scientific background with at least 10 years of experience in Clinical Regulatory Affairs in the biotechnology or pharmaceutical industries, related experience may be considered
  • Extensive experience in preparation, submission and approval of INDs/CTAs and marketing applications (NDA/BLA/MAA).
  • Proven ability to successfully manage major submissions and critical projects timelines.
  • Experience in addressing clinical-related regulatory queries from global health authorities
  • Experience with leadership role in HA negotiations.
  • Excellent medical writing, communication and management skills.
  • Regulatory Affairs Certification (RAC) preferred
  • Must speak Mandarin fluently



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