Regulatory Affairs Senior Manager

This successful biopharma company develops and commercializes innovative cancer immunotherapies. They are seeking a Regulatory Affairs Senior Manager who can contribute to regulatory strategies for multiple novel immune-oncology programs.  You will work closely with cross-functional teams to advance programs through the pipeline towards approval.  This company offers competitive compensation, great employee benefits and cutting-edge science. Now is an exciting time to join this growing organization and make an impact in the fight against cancer!

Responsibilities:

  • Contribute to and execute on regulatory strategies for immune-oncology programs in development.
  • Provide regulatory guidance to cross-functional teams ensuring that assigned projects progress from IND stage to launch within company agreed timelines.
  • Participate in cross functional teams and manage the preparation of applications and subsequent US-based regulatory documents, pre and post approval in accordance with agreed timeframes.
  • Review complex technical documents for regulatory submissions.
  • Prepare and/or manage submissions that are technically complex and ensure submission-readiness of all regulatory documents related to the assigned projects.
  • Ensure that documents are compliant with US eCTD submission requirements.
  • Interact with health authorities and respond to FDA queries.
  • Build long term effective relationships with cross functional teams in order to provide accurate information and timeframes.
  • Maintain current knowledge of relevant regulations.
  • Assist and mentor in developing junior regulatory affairs staff.

Qualifications:

  • Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
  • Six or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
  • Experience supporting regulatory filings such as INDs, CTAs, NDAs, MAAs and/or BLAs.
  • Prior biologic therapeutic and/or oncology regulatory experience preferred.
  • Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Willingness to think outside of the box and adapt best practices.
  • Ability to adapt in a constantly evolving environment.
  • Self-motivated with a strong sense of ownership in areas of responsibility.
  • High degree of professionalism, ethics and integrity.

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