Director, Quality Assurance
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
- Regulatory knowledge and expertise in clinical drug product development are the primary skillsets required for this position.
- Involvement in all aspects of the clinical development process is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Licensure), participation in multiple project teams, development of regulatory strategy and discussions with the applicable Health Authorities are key expectations and requirements of the position.
- In depth knowledge and understanding of applicable US regulations/guidelines for drug and biologic products is also required. Ex-US regulatory experience is a significant plus.
- The individual will be asked to participate on program teams in support of the Regulatory function, liaise with third parties representing RA, and is responsible for the notification and inclusion of the most appropriate individuals within the company based upon how critical of the issues to be addressed.
- Perform any other business need identified by their direct line Manager.
- BA/BS required.
- 2-5 years of applicable regulatory affairs experience required unless candidate has Regulatory Affairs Master’s degree.
- Thorough knowledge of FDA and biologics regulations, familiarity with ICH guidelines regarding clinical studies and understanding of both the IND, NDA, and BLA processes/structures is required.
- Experience working on project teams is required.
- Candidate should be a self-driven individual with skills in organization, building working relationships and communication.
ABOUT DISC MEDICINE:
Disc Medicine is a biopharmaceutical company dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and financed by Series A lead investor Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture. Disc Medicine values communication, professional development, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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