Director Global Regulatory Affairs
The Disc Medicine Team is 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. We value transparency, authentic communication, and scientific rigor and promote a company culture in which differences are celebrated and all individuals are valued.
Disc Medicine is hiring a new Director, Global Regulatory Affairs due to the fast growth of the company’s portfolio. Disc Medicine is currently initiating clinical trials with biologic programs (monoclonal antibody).
Reporting into the Head of Global Regulatory Affairs, this position is located within Disc Medicine’s Watertown, MA office, although remote work is available for this role. This position will have visibility to the development teams as well as the executive leadership team and will have meaningful opportunities for professional development and career growth.
RESPONSIBILITIES OF DIRECTOR GLOBAL REGULATORY AFFIARS:
- Act as primary regulatory representative for Disc Medicine biologic programs
- Define and execute the company regulatory strategy for the biologic programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks
- Have and maintain in-depth knowledge and understanding of applicable US/EU regulations for biologic products
- Coordinate and manage global RA submissions to ensuring phase-appropriate and compliant RA applications are submitted globally
- Ensure Disc’s compliance with regulatory requirements and Disc Medicine internal Standard Operating Procedures (SOPs)
- Author, review, and/or approve documentation, regulatory strategies, and RA global content for applicable submissions/programs. Provide appropriate RA oversight of Disc Medicine programs as well as
- Ensure global regulatory conformance and consistency with internal procedures and high scientific standards for quality; providing an assessment of best practices for improvements in current process(es), as needed
- Represent the company on communications and in meetings with health authorities, assessing impact of new regulations, managing regulatory documents, etc. You will also be negotiating with regulatory authority personnel to expedite review and approval of pending submissions as well as respond to queries
- Technical review(s), as requested, to ensure quality RA submissions to determine appropriate reporting or regulatory strategy
- Ex-US RA experience is a significant plus
- Collaborating with internal and external Disc Medicine stakeholders to make science-driven, phase-appropriate, and risk-based decisions, and proactively identify gaps and design mitigation strategies
- Interact effectively with functional leads as CMC, nonclinical, clinical, and other stakeholders across Disc Medicine. Participate on program teams in support of the RA function, liaise with third parties representing RA, and be responsible for the notification and inclusion of the most appropriate individuals within the company to address priority issues
- Anticipate new or changing regulations and coordinate with internal stakeholders to develop strategies to address any of these potential changes
- BA/BS required, Ph.D. or other graduate degree preferred
- A minimum of 8 years total pharmaceutical/related industry experience
- A minimum 6 years regulatory experience
- Experience interacting with applicable health authorities
- Thorough knowledge of FDA drug and biologics regulations, experience with regulators internationally is a plus
- Experience with product labelling strategy
- Familiarity with ICH guidelines regarding oversight of development programs
- Experience in all aspects of clinical development is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Commercial/Licensure)
- Experience working on project teams. Candidate should be a self-driven individual with skills in organization, building working relationships and communication
- Experience with development of business processes, procedures, and/or templates to guide RA development
ABOUT DISC MEDICINE:
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.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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