Regulatory Affairs Specialist

4 weeks ago

Durham, United States Planet Pharma Full time

*Relocation Assistance Available*

Responsibilities:

  • Responsible for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions.
  • Responsible for the preparation of regulatory and ethics committee submission dossiers, including applications for import and export licenses, where applicable.
  • Responsible for reviewing translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).
  • Primary responsibility for tracking regulatory project documentation flow and progress reporting.
  • Supervised responsibility for maintaining a database of regulatory requirements.
  • Primary or secondary responsibility for registration/marketing authorization projects and renewals (where applicable).
  • Responsible for the compilation and review of Investigational New Drug Applications (INDs).
  • Primary or secondary contact person for ethics committees and regulatory authorities, project teams on all regulatory-related issues, and co-contractors, subcontractors, and third- party vendors (regulatory issues).
  • Secondary responsibility for the development and update, if necessary, of project planning documents, including project timelines (regulatory aspects) and safety management plan, where applicable (in cooperation with Medical Affairs).
  • Responsible for review of investigational product release-enabling documents.
  • Primary or secondary responsibility for training company employees in
  • regulatory practices.
  • Responsible for ensuring accurate and time-bound reporting of
  • safety issues to authorities and reviewing incoming safety reports for completeness.
  • Provide assistance to business development at client presentations, bid defense meetings, and the like in various regulatory aspects (at the discretion of Senior Regulatory Affairs staff).

Qualifications

  • Must have a College/University degree or an equivalent combination of education, training and experience.
  • Must have 3+ years of hands-on relevant Regulatory Affairs experience.
  • Experience with the review, maintenance, and compilation of the IND lifecycle and submissions.
  • Experience interacting with and acting as the liaison with the FDA/Sponsor/ etc.
  • Prior experience with Health Canada is a plus.
  • Proficiency in MS Office applications.
  • Detail-oriented, ability to learn, plan and work in a dynamic team environment.
  • Must have excellent communication, collaboration, and problem-solving skills.

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