Development: Sr. Associate/Manager of Regulatory Operations

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit elusive frontier targets within notorious growth and survival pathways, with particular emphasis on RAS and mTOR signaling pathways. As a new member of the RevMed team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

Opportunity

The ideal candidate will provide regulatory operations support for early development programs across functions, organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, safety reports, and pre-meeting packages, provide regulatory writing support. Key responsibilities will include:

  • Interaction with cross-functional team members and document owners to obtain final documents for regulatory submissions.

  • Communication with Regulatory Operations vendor to facilitate publishing of regulatory submissions including conducting QC, answering questions, archiving of submission documents in internal systems.

  • Monitor and track incoming serious adverse events (SAEs) from Pharmacovigilance vendor for clinical studies, particularly for SAEs that require expedited reporting to FDA and include:

  • Set calendar for due dates of cases that require regulatory submission

  • Engage with Drug Safety staff as needed in support of SUSAR submissions

  • Coordinate with internal drug safety representative and/or drug safety vendor to obtain final MedWatch or CIOMS form for submission

  • Notify Pharmacovigilance vendor of FDA submission and date of submission

  • Create cover letters and 1571 forms to accompany all submissions and addressing comments from reviewer.

  • Provide Regulatory writing support as needed.

Required Skills
  • Bachelor’s degree in a relevant scientific or life sciences discipline.

  • Minimum 2 years of Regulatory Operations experienced required.

  • Experience in managing and publishing of regulatory submissions for investigational or marketed products is preferred.

  • Knowledge of global health authority regulations and guidelines.

  • Excellent verbal and written communication skills.

  • Ability to work independently with minimal supervision or direction.

  • Excellent written and verbal communication skills to work with interdepartmental teams.

  • Innovative, team-player with high energy for our small company environment.


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