Director-Sr. Director, Global Regulatory Affairs - Redwood City California

Company: Fusion Health
Location: Redwood City, California
Posted On: 04/18/2024

At Biomea Fusion, Inc., we aim to cure in oncology and diabetes. We are seeking an experienced and highly motivated regulatory professional to support our clinical development programs and future marketing applications. Reporting to the Executive -Director, Regulatory Affairs, the Director/Sr. Director, Global Regulatory Affairs is the regulatory strategic leader on one or more clinical programs, responsible for developing and implementing innovative regulatory strategies for Biomea's clinical programs that have the potential to address critical unmet needs. This role is onsite at least 3-days per week.
Essential Responsibilities:

• Primary regulatory strategic advisor & team member for the product development team(s). Translates complex regulatory issues into actionable strategies. -
  
• Demonstrates an exceptional understanding of country requirements for investigational and marketing applications, i.e., INDs, NDA/BLAs, IMPDs, CTAs, DM, Fs, and MAAs - overseeing the planning and execution of those applications and subsequent submissions to regulatory authorities within the company requirements and timelines, regulations and guidelines.
  
• Assess situations and make and carry through complex decisions.
  
• Identifies future risks and provides solutions before the risks become a barrier to producing quality deliverables on time.
  
• Contributes to the strategic leadership and growth of the regulatory function, including developing processes and best practices commensurate with a rapidly growing company. -
  
• Limited travel may be required. -
  
• Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.
  
  Education and Experience Requirements:
  
  
  
  • Graduate degree with 10 years or Bachelor's degree with 15+ years in biopharmaceutical industry with a proven record of significant regulatory accomplishments.
    
  • Detailed knowledge and understanding of US FDA and EU regulatory regulations, guidance and procedures for investigational and commercial products; a good knowledge of requirements in other key territories.
    
  • Experience with both early and late-stage drug development.
    
  • Capable and competent in setting strategies as well as taking a hands-on approach to all regulatory activities.
    
  • A successful track record of preparing regulatory documents including new INDs, NDAs/BLAs, MAAs, CTAs, IMPDs, PIPs, amendments, safety reports, annual updates, and documents for other regulatory submissions.
    
  • Prior experience working at a small company with wide ranging related responsibilities is an advantage.
    
  • Prior experience in oncology is preferred.
    
  • Excellent verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
    
  • Ability to thrive in a collaborative and fast-paced team environment.
    
    Compensation:
    The anticipated salary range for fully qualified candidates applying for this role is from $200,000 to $250,000. -The actual title and salary offered is based multiple factors including education, relevant industry experience, and length of industry experience; these factors will influence the actual title and salary offered. -Our competitive salary is only one part of the overall total rewards program, which includes the opportunity to participate in stock programs, performance-based bonus programs and a competitive benefits package.
    Equal Employment Opportunity:At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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