Associate Director-Director, Regulatory Affairs
Company: Fusion Health
Location: Redwood City
Posted on: September 14, 2023
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.
- Lead interactions and act as Subject Matter Expert on
regulatory pharmaceutical and/or biotechnology projects in a
- 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
- May include directly or indirectly supporting a variety of
projects and submissions.
- Manage timelines and expectations to ensure a positive
- 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
- 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
- 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
- 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
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
Keywords: Fusion Health, Redwood City , Associate Director-Director, Regulatory Affairs, Executive , Redwood City, California
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