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Regulatory Affairs Associate

Reporting to the Senior Manager, Regulatory Affairs CMC, you’ll be responsible for:

  • Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual Reports.

  • Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.

  • Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time.

  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks.

  • Ensuring consistent and appropriate communication within the department and with other functional areas.

  • Interfacing with global Regulatory partners, internal cross functional teams, and consultants.

  • Assisting in the preparation for meetings with global regulatory authorities.

  • Attending relevant functional area and project team meetings.

  • At least 2 years of experience in Regulatory Affairs or a related function such as Quality or Process Development in a global Pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products).
  • Outstanding interpersonal and communication (written and verbal) skills is required.
  • Strong writing and editing skills for technical documentation.
  • Project management skills are a plus.
  • Proficient with computer and standard software programs.
  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.
  • Advanced degree is a plus.
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