Regulatory CMC Specialist

Location: New York, NY

Salary: $60,000 to $110,000

Our client is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.

Responsibilities Include:

  • Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Liaise with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned products across the product lifecycle
  • Identify and communicate potential regulatory issues to GRACS CMC, as needed
  • Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies.
  • The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products

 Experience Required:

  • Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
  • Experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.
  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.
  • Demonstrated effective leadership, communication, and interpersonal skills.