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!
- 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.
- 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.