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.

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.

Roles and Responsibilities:

  • 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

Education and Experience:

  • 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.