Position Summary:
Reporting to the Vice President, Regulatory Affairs, the Associate Director, Regulatory Affairs will support the company's regulatory affairs strategies needed for IND/CTA/BLA/NDA filings and approvals. The Associate Director, Regulatory Affairs is a key member of project teams and is responsible for managing the day-to-day tasks required to achieve regulatory goals across multiple programs. The Associate Director, 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 (Monday/Tuesday & Thursday).
Essential Responsibilities:
* Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology projects.
* 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 8 years of progressive regulatory experience in Regulatory Affairs for pharmaceutical and/or biotechnology company.
* Experience with Phase 1 through Phase III products (IND/CTA) and/or marketing applications (US/EU) is highly desirable.
* Demonstrated experience supporting regulatory writing and electronic submission.
* Experienced supporting regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs.
* Proven direct experience interacting with the FDA and other health authorities is highly desired.
* The ideal candidate must be able to cover all aspects of regulatory affairs including Development, CMC, and Operations.
* Ability to interpret trends in the US FDA regulatory environment, is preferred.
* Strong oral and written communications skills as well as the ability to cultivate cross-functional relationships and work collaboratively with other groups, is required.
* The ideal candidate will be entrepreneurial, innovative, energetic, hands-on, team-oriented, and customer-focused, with the ability to think strategically while managing project details.
* Must be comfortable working in a small, fast-paced environment with a high level of ambiguity.
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 based on 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.
Compensation:
The expected salary range for this role is $170,000 to $190,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in a role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program, which includes competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.
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