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Regulatory Specialist & Project Manager REF: 1115

This position is responsible for providing RA support for a marketed product portfolio – products lifecycle and maintaining compliance with US Food and Drug Administration (FDA) regulations.

The role of the Regulatory Affairs Associate is to provide support for Existing Product Development (EPD) during lifecycle management. You will be working cross-functionally and providing support to teams such as Regulatory Strategy/CMC, Regulatory Operations, Promotional Review Committee (PRC), and Risk Evaluation and Mitigation Strategy (REMS). You should be a team player who listens objectively, exercises good judgment, asks incisive questions and is able to perform and track multiple tasks on several projects.

The responsibilities of this job include, but are not limited to, the following

  • Prepare and manage regulatory submissions (e.g., supplements, amendments, correspondence to FDA, etc.) as well as support key stakeholders in the preparation, and QC for investigational and/or marketed drug products
  • Develop relationships with key stake holders (e.g., Regulatory Operations) to establish and maintain submission planners and associated timelines and facilitates tactical submission team meetings
  • Provide support to Regulatory REMS as assigned (e.g., research regulations, guidance, submission support, etc.).
  • Coordinate and support the team in planning and preparation for FDA meetings and/or teleconferences.
  • Maintain and update internal records in appropriate document management systems.
  • Provide backup for the PRC coordinator and monitor the PRC process.

Submission/Activity Preparation

  • Work with internal teams to establish appropriate procedures for submission(s) per SOPs
  • Assist with drafting cover letters, FDA forms and response documents as necessary
  • Create regulatory objectives in the appropriate document management system.
  • Maintain a submission calendar and work closely with internal teams to schedule, upload appropriate documents and route documents for review and approval to meet submission deadlines.
  • Provide support with Annual Reports by holding kick-off meetings, coordinate section updates/review.
  • Lifecycle submissions, upload health authority correspondences and keep the regulatory system up to date with all submission activity

MINIMUM QUALIFICATIONS:

  • Bachelor degree in science related field, business, healthcare or other related discipline
  • 1-3 years of Pharmaceutical experience preferably in a regulatory environment
  • Some knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
  • Excellent communication skills, both verbal and written
  • Contract Type:

    Contract opportunity

  • Location:

    US based, remote working

  • Duration:

    6 months initially

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