Director, Global Regulatory Affairs
Director, Global Regulatory Affairs
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
Disc Medicine has a new role in its Regulatory team for a Director of Global Regulatory Affairs, who will act as the primary representative for one of our programs. Reporting directly to the Vice President of Global Regulatory Affairs, this position will have visibility within the development and executive leadership teams. It will also offer significant opportunities for professional development and career growth.
- Act as a primary regulatory representative for Disc Medicine biologic programs.
- Define and execute the company regulatory strategy for the assigned 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 ensure phase-appropriate and compliant RA applications are submitted globally.
- Ensure Disc’s compliance with regulatory requirements and Disc Medicine’s 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.
- Ensure global regulatory conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es), as needed.
- Represent the company in communications and meetings with health authorities, assess the impact of new regulations, manage regulatory documents, etc. You will also negotiate with regulatory authority personnel to expedite reviewing and approving pending submissions and 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 such as CMC, nonclinical, clinical, and other stakeholders across Disc Medicine. Participate in program teams supporting 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 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 of 6 years of regulatory experience.
- Experience interacting with applicable health authorities.
- Thorough knowledge of FDA drug and biologics regulations and experience with regulators internationally is a plus.
- Experience with product labeling 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. The candidate should be a self-driven individual with organizational skills, building working relationships, and communication skills.
- Experience developing business processes, procedures, and/or templates to guide RA development.
Disc Medicine is an equal opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to our Human Resources Department at email@example.com and include the title of the position you are applying for in the subject line.
Please note that agency phone calls or submissions will not be accepted.
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