CMC Regulatory Affairs Director
Disc Medicine is hiring a new CMC Regulatory Affairs Director due to the fast growth of the programs in the clinic. Disc is currently initiating clinical trials with a biologic program (monoclonal antibody DISC-0974) and a small molecule (bitopertin).
This position is located within Disc Medicine’s Watertown, MA office, although remote work is currently in effect and open for this role. We are looking for someone who is seeking growth and strategic opportunities to deepen their CMC RA career, with a team that provides opportunities and visibility to both the development teams and the Executive leadership team.
Excellent quality, time management and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment and with both in office and remote team members.
RESPONSIBILITIES OF CMC RA DIRECTOR:
- Define the company CMC regulatory strategy for the biologic and small molecule programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks
- Leading chemistry, manufacturing, and control (CMC) Regulatory initiatives across Disc Medicine’s portfolio
- Creating and driving CMC RA deliverables and ensuring that phase-appropriate and compliant CMC RA applications are submitted globally
- Authoring, reviewing, and/or approving documentation, regulatory strategies, and CMC RA global content for applicable submissions/programs. Provide appropriate CMC RA oversight of Disc Medicine programs as well as coordinate and manage global CMC RA submissions to ensure compliance to regulatory expectations and adherence to relevant Disc change control procedures
- 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 CMC submissions and thorough CAPA assessment to determine appropriate reporting or regulatory strategy
- In depth knowledge and understanding of applicable US regulations/guidelines for drug or biologic products is also required. Ex-US CMC 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
- Interacting effectively with functional leads and other stakeholders across Disc Medicine. The individual will be asked to participate on program teams in support of the CMC RA function, liaise with third parties representing CMC RA, and is responsible for the notification and inclusion of the most appropriate individuals within the company to address priority issues
- Experience in all aspects of the clinical development is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Commercial/Licensure), participation in multiple project teams, development of quality strategy and discussions with the applicable Health Authorities are key expectations and requirements of the position
- Perform any other business need identified by their direct line Manager
- BA/BS required, Ph.D. or other graduate degree preferred
- 7+ years of applicable CMC RA experience required unless candidate has advanced degrees/certification. Quality mindset is a must
- Thorough knowledge of FDA drug and biologics regulations, experience with regulators internationally is a plus
- Familiarity with ICH guidelines regarding oversight of development programs
- Experience working on project teams is required. 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 CMC 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 email@example.com
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