Director, Global Regulatory Lead at Disc Medicine

, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Jan, 26

Salary

261050.0

Posted On

29 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Biologic Programs, Health Authorities, Regulatory Submissions, FDA Regulations, EMA Regulations, PMDA Regulations, ICH Guidelines, Clinical Development, Project Teams, Business Processes, Communication Skills, Organizational Skills, Collaboration, Risk Management, Scientific Integrity

Industry

Biotechnology Research

Description

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 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: Reporting to our Vice President of Global Regulatory Affairs, we are hiring a Director, Global Regulatory Lead to support the fast growth of the company’s portfolio. The successful candidate will serve as the primary regulatory representative for assigned biologic program(s) in Disc Medicine’s pipeline. This position will have visibility to the development teams and executive leadership with meaningful opportunities for professional development and career growth. RESPONSIBILITIES: Lead the company’s global regulatory strategy for select Disc investigational programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks. Act as a primary regulatory representative for assigned Disc Medicine programs. Represent the company in communications and meetings with health authorities, assess new regulations' impact, manage regulatory documents, etc. Have and maintain in-depth knowledge and understanding of applicable US/EU regulations on development for biologic products. Lead regulatory 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 regulatory content for applicable submissions/programs. Provide appropriate regulatory oversight of Disc Medicine programs. Ensure regulatory conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es). 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 development. Interact effectively with functional leads such as 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 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 12-15 years regulatory experience and 12 years of total pharmaceutical/related industry experience. Experience interacting with applicable health authorities. Thorough knowledge of FDA, EMA, PMDA, regulations and experience with other regulators internationally is a plus. Familiarity with ICH guidelines regarding oversight of development programs. Experience in aspects of development during different phases of clinical development (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3, and NDA/BLA/MAA). 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. The annual base salary range for this position is listed below. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and internal parity. Salary Range $192,950—$261,050 USD 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 be considered for current and future opportunities.

Responsibilities

Lead the global regulatory strategy for investigational programs and act as the primary regulatory representative for assigned programs. Ensure compliance with regulatory requirements and collaborate with internal and external stakeholders to make informed decisions.