Director-Sr. Director, Regulatory Operations
Location
Redwood City, CA | United States
Job description
Position Summary:
Develop, implement, lead, and perform regulatory operations activities within Biomea Fusion, Inc. in support of electronic submissions (e.g., IND, NDA) to FDA and to ex-US regulatory agencies. Working closely with IT, develop and maintain electronic archives for regulatory submissions, collaboration sites, and company due diligence rooms for all Biomea Fusion, Inc. projects. Serve as regulatory operation lead for efforts to implement publishing and regulatory information management systems. This position reports into the Vice President, Head of Regulatory Affairs.
Essential Responsibilities:
- Lead electronic publishing efforts in support of electronic submission of INDs and NDAs to FDA and other ex-US regulatory agencies as required. This may include oversight of contract regulatory publishing resources.
- Prepare documents in all disciplines (e.g., CMC, nonclinical, clinical, and regulatory) to meet applicable standards for submissions in eCTD format; prepare same documents for paper submission, if/when required.
- Serve as the primary interface with publishing vendors to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed.
- Implement use of templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and training to team members.
- Provide expertise in evolving global regulatory and technical submission requirements with regard to preparation, format, and structure.
- Develop and maintain electronic archives for regulatory submissions, collaboration sites, and company due diligence rooms for all Biomea Fusion, Inc. projects.
- Collaborate with internal IT resources and external vendors for successful implementation and efficient use of electronic systems, including acting as the regulatory business owner on implementation of submission publishing and regulatory information management systems.
- Provide direct support to program teams and functional disciplines responsible for developing and delivering components for regulatory submissions.
- Manage all aspects of global submissions, publishing, validation, and regulatory system implementations (e.g., Veeva Vault RIM).
- Serve as the administrator for RIM and provide subject matter expertise to support project teams in the development of components for various regulatory submissions.
- Organize and maintain regulatory correspondence and archives to prepare for migration into RIM system.
- Author and/or collaborate on standard operating procedures for the regulatory operations function.
Education and Experience Requirements:
- Bachelor's degree in a scientific discipline or systems technology or equivalent combination of education and experience.
- At least 10-12 years of relevant regulatory experience in pharma/biopharma required.
- Strong leadership skills, leading teams and complex projects within Regulatory and across functional teams. Experience in coaching and managing others.
- Expert knowledge of eCTD publishing systems, EDMS/RIM technology, and related publishing tools.
- Advanced knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.). Able to advise and/or train project teams on new requirements, along with proposals for implementation.
- Strong communication, strategic thinking, and problem-solving skills coupled with strong presentation skills.
- Computer proficiency in Microsoft Office including Word, Excel, PowerPoint, and Project.
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
Industry:
Employment Type:
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 characteristics.
The anticipated salary range for qualified candidates for this role is $220,000 to $250,000. An individual's position within the range is influenced by multiple factors, including education, relevant work experience, tenure, and market dynamics. These factors will determine the actual salary offered. In addition to the competitive base salary, we all offer a performance-based discretionary bonus program, equity awards and comprehensive benefits program.
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