Proclinical is currently recruiting for a Director of Global Regulatory Affairs for a biopharmaceutical company located in Jersey City, NJ. Successful candidate will primarily serve as the Global Regulatory Team Lead for a Phase 3 program and anticipated NDA/MAA filings, as well as other development candidates, as needed.

Job Responsibilities:

  • Develops and implements innovative global regulatory strategies for assigned programs through collaboration with a cross functional project team and consensus-building with internal and external stakeholders.
  • Leads team in the development and execution of key deliverables to support Phase 3 and registration, such as Company Core Data Sheet and USPI/SmPC, NDA/MAA submission strategy and planning, coordination, and preparation for successful interactions with regulatory authorities.
  • Establishes and maintains relationships with regulatory agency counterparts. Negotiates directly with regulators regarding company's filings to ensure high likelihood of success.
  • Effectively communicates the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs management as well as the senior management team, as needed
  • Maintains awareness of the evolving regulatory landscape and advises team and management of changes with potential strategic impact to future development. Interprets regulations, guidelines, and policy statements on a global level
  • Coordinates timely submissions to health authorities and monitors reporting requirements to maintain compliance with applicable regulations
  • Interact with company partners and consultants for various regulatory matters, as needed
  • May be responsible for line management and development of direct reports
  • Skills and Requirements:

  • BS or MS in life sciences with 7-10+ years of pharmaceutical/biotechnology industry experience, predominantly in Regulatory Affairs; Advanced degree (PhD, PharmD) and/or RAPS certification is a plus
  • Experience in the preparation and successful submissions of INDs, and approval/post-approval management of NDAs in the US; filing experience in other ICH regions desirable
  • Direct experience interfacing with global Health Authorities
  • Experience in CNS therapeutic area and/or Rare Disease drug development preferred
  • Strong leadership and project management skills, including demonstrated cross-functional communication, negotiation and conflict management skills
  • Ability to represent department in project teams, committees, and external meetings, as well as with executive management, partners, and collaborators
  • Comprehensive working knowledge of applicable regulations in ICH regions and solid knowledge of GCPs and GLPs
  • Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences

  • Associated topics: business, demand generation, event, facebook, hospital, market, newspaper, policy, presale, solicitation

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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