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Associate Director-Director, Regulatory Affairs

Company: Fusion Health
Location: Redwood City
Posted on: September 14, 2023

Job Description:

Reporting to the Executive Director, Regulatory Affairs, the Manager/Sr. Manager, Regulatory Affairs will support the company's regulatory affairs needed for IND/CTA/BLA/NDA filings and approvals. The Manager/Sr. Manager, Regulatory Affairs is a key member of project teams and is responsible for the managing the day-to-day tasks required to achieve regulatory goals across multiple programs. The Manager/Sr. Manager, Regulatory Affairs is expected to bring knowledge of the clinical development process and regulatory requirements, strong project management and vendor management skills, and excellent communication and writing skills to ensure that company submissions meet regulatory and company standards with high quality and within stated timelines. This role is onsite at least 3-days per week.
Essential Responsibilities:

  • Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology projects in a multi-functional team.
  • Collaborate with internal staff to author and support submissions to achieve successful approvals of clinical trials and marketing applications (including INDs, CTAs, BLAs, MAAs, and NDAs).

    • May include directly or indirectly supporting a variety of projects and submissions.
    • Manage timelines and expectations to ensure a positive experience.
    • Act as SME with deep knowledge of regulations for all aspects of pharmaceutical development including interpreting regulations and applying appropriate regulatory risk management strategies designed to identify potential risk, evaluate consequences, and provide solutions to address needs.
    • Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
    • Manage, oversee and/or prepare regulatory documents and submissions in accordance with Biomea Fusions requirements.

      • Prepare presentations as needed.

        Education and Experience Requirements:

        • Bachelor's or master's degree in a scientific field.
        • At least a minimum of 6 years of regulatory experience, especially in Clinical Regulatory Affairs for pharmaceutical and/or biotechnology products; experience with Phase 1 through Phase III products (IND/CTA) and/or marketing applications (US/EU) is highly desirable.

          • Demonstrated experience supporting regulatory writing, electronic submission and format requirements.
          • Proven experience in contributing to the preparation of INDs, CTAs, NDAs, MAAs and/or BLAs for submission to the Regulatory Agencies.
          • Direct experience working with the FDA and other health authorities is highly desired.
          • Must be able to cover all aspects of regulatory affairs including Development, CMC, and Operations; experience in clinical regulatory is highly desirable. -
          • Must be able to interpret trends in the FDA/EMA/ICH regulatory environment.

            • Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
            • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
            • Must be comfortable with ambiguity in a small, fast-paced environment.

              The expected salary range for the Manager, Regulatory Affairs role is $140,000 to $160,000 and for the Sr. Manager role is $160,000 to $175,000.------ An individual's position within the range is based on multiple factors including education, relevant experience and length of industry experience. These factors will influence the actual title and salary offered. In addition to competitive salary, Biomea Fusion, Inc. offers 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.

Keywords: Fusion Health, Redwood City , Associate Director-Director, Regulatory Affairs, Executive , Redwood City, California

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