Careers

Senior Manager European Regulatory Affairs

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:

Due to the fast growth of the company’s portfolio, Disc Medicine is hiring a new Senior Manager, European Regulatory Affairs. The successful candidate will serve as the primary European regulatory 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 with meaningful opportunities for professional development and career growth. This position is in the Netherlands Almere office, with remote options available. 

RESPONSIBILITIES:

• Define and execute the company’s European regulatory strategy for Disc programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks.
• Have in-depth knowledge and understanding of applicable EU regulations on developing medicinal products. 
• Coordinate and manage EU submissions and Clinical Trial Applications to ensure phase-appropriate and compliant RA applications and the current European guideline and systems.
• Ensure Disc’s compliance with regulatory requirements and Disc Medicine’s internal Standard Operating Procedures (SOPs). 
• Author, review, and approve documentation, European regulatory strategies, and RA content for applicable submissions/programs.  
• Ensure regulatory conformance and consistency with internal procedures and high scientific standards for quality; assess best practices for improvements in the current process(es), as needed.
• Represent the company in communications and meetings with health authorities, assess new regulations’ impact, manage European regulatory documents, etc. 
• Perform technical review(s), as requested, to ensure quality RA 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 RA 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 European regulations on development and coordinate with internal stakeholders to develop strategies to address any of these potential changes.

REQUIREMENTS:

• 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 European regulatory experience. 
• Experience interacting with applicable health authorities.
• Thorough knowledge of EMA and European national Health Authorities and experience with other regulators internationally is a plus.
• Familiarity with ICH guidelines regarding oversight of development programs.
• Experience in all aspects of 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 templates to guide European RA strategy.

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