Careers

Senior Director Regulatory Affairs CMC

COMPANY OVERVIEW:

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.

POSITION OVERVIEW:

Disc Medicine is hiring a new Senior Director, Regulatory Affairs CMC due to the fast growth of the company’s portfolio. The successful candidate will serve as the primary regulatory CMC representative for Disc Medicine’s small molecule and biologic program pipeline. Reporting to the Head of Global Regulatory Affairs, this position will have visibility to the development teams and executive leadership with meaningful opportunities for professional development and career growth. 

RESPONSIBILITIES:

• Define and execute the company’s global regulatory strategy on CMC development for all Disc programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks.
• Lead and grow the Regulatory CMC team at Disc.
• Have and maintain in-depth knowledge and understanding of applicable US/EU regulations on CMC development for biologic products. 
• Coordinate and manage RA CMC 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 CMC strategies, and RA CMC content for applicable submissions/programs. 
• Provide appropriate RA CMC oversight of Disc Medicine programs. 
• Ensure regulatory CMC conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es).
• Represent the company in communications and meetings with health authorities, assess new regulations’ impact, manage regulatory CMC documents, etc. 
• Technical review(s), as requested, to ensure quality RA CMC submissions to determine appropriate reporting or regulatory strategy.
• Collaborate with internal and external Disc Medicine stakeholders to make science-driven, phase-appropriate, and risk-based decisions, proactively identify gaps and design mitigation strategies for CMC development.  
• 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 on CMC development and coordinate with internal stakeholders to develop strategies to address any potential changes.

REQUIREMENTS:

• BA/BS required, Ph.D. or other graduate degree preferred.
• A minimum of 12 years of total pharmaceutical/related industry experience. 
• A minimum of 10 years regulatory CMC experience. 
• Experience interacting with applicable health authorities.
• Thorough knowledge of FDA, EMA, PMDA, and CDE regulations and experience with other regulators internationally is a plus.
• Ex-US RA CMC experience in the EU and Asia is required. 
• Familiarity with ICH guidelines regarding oversight of development programs.
• Experience in all aspects of CMC development during different phases of clinical development (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 CMC 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 careers@discmedicine.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.  

Interested in joining our team? Please contact us at careers@discmedicine.com