Position: Regulatory Affairs, Senior Director/Executive Director/Vice President
Job: #2442
Location: Central NJ
Compensation: Based Upon Experience
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 eight (8) 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.