BioAge Labs, Inc. (BioAge) is a venture-backed biopharmaceutical company headquartered in Richmond, CA. BioAge believes that aging is the fundamental driver of many highly morbid, chronic diseases that reduce both the quantity and quality of life. We believe that intervening directly in the aging process will be the most impactful way to decrease the burden of disease and increase healthspan in an aging population.
The Senior Manager, Regulatory Affairs will fill the role of a global regulatory leader responsible for managing regulatory affairs activities (nonclinical, clinical, and safety) for one or more development programs in diseases of aging. This individual is accountable for the execution of the regulatory strategy, and for representing Regulatory Affairs in cross-functional teams and with external partners. Working alongside senior Regulatory staff, this individual will be a key contributor to BioAge’s integrated program and regulatory team. Assures appropriate policies/procedures/systems are in place and followed to ensure company compliance with applicable regulations and industry best practices.
Leads and supports the preparation, submission, and maintenance of regulatory applications, including initial clinical trial applications, routine amendments, briefing documents, annual reports, safety reports, and responses to health authority inquiries
Interacts with the CMC, Quality, Preclinical, Nonclinical, Clinical Science, Clinical Operations, and other functions to ensure optimal execution of the agreed regulatory strategy for investigational products
Participates in cross-functional teams, providing regulatory feedback and support
Assists in project-related interactions with external collaborators and vendors
Prepares product prioritization designation requests, e.g., fast track, breakthrough therapy, accelerated approval, etc., in US and ex-US, respectively
Authors and works with technical and medical writers to manage document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and high-quality document deliverables
Assists with preparation for and attends regulatory authority meetings, including question formulation, meeting requests, briefing packages, meeting participant training, mock meetings, preparation/review of sponsor draft minutes, review of Agency formal minutes
Coordinates with electronic publishing vendors to ensure timely and accurate submissions
Maintains archive and tracking of ongoing submissions and correspondence
Completes other responsibilities as assigned and/or agreed upon
Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
Advanced degree in biological or life sciences, pharmacy, or medicine with 10+ years experience in pharmaceutical development research or relevant work experience and 5+ years in Regulatory Affairs.
Experience in the preparation and submission of regulatory documentation to support Agency review/approval procedures, post-approval activities (e.g., components of IND, NDA, target product profiles, integrated development plans)
Strong knowledge base and understanding of FDA regulations (ex-US is a plus), including nonclinical requirements to support IND and NDA/BLA, ICH, GXPs
Experience representing Regulatory Affairs on cross-functional teams
Excellent planning and organizational skills and adept at prioritizing and completing tasks on multiple projects within established timelines
Ability to prepare and manage the scope of work, budget, and timelines for programs/projects to facilitate the achievement of key project milestones
Exceptional written (including excellent technical writing ability), verbal, and interpersonal communication skills with a broad audience (e.g., leadership, team members, partners, collaborators, consultants, vendors, and Health Authorities)
Proven leadership within a cross-functional project team
Demonstrated ability to anticipate and address issues
Ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures
US Regulatory Affairs Certification is desirable
Experience in nonclinical regulatory authoring/review is desirable
Experience in aspects of clinical development such as protocol design, and clinical operations, such as feasibility and DSMB/DMC is a plus
BioAge offers a comprehensive compensation package, as well as generous paid time off in addition to company-observed holidays. We provide medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions. We also pride ourselves in giving employees many opportunities for career development including a generous annual budget for continued learning, a direct and open-door environment, and a dedication to training and skill development.
BioAge is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.