Position Summary:

The Vice President, Regulatory Affairs is responsible for developing and driving the global regulatory strategy to advance the clinical development of drug candidates for the company.

Essential Job Duties:

• Develop the global regulatory strategy from current phase of development through marketing approval
• Responsible for directing all regulatory activities for the company including:
• Organization, production, and submission of domestic and international regulatory filings, such as INDs, CTAs, NDAs, BLAs, MAAs, responses to health authorities, amendments, DSURs, Orphan Drug Designation applications, all regulatory maintenance activities, etc.
• Interactions with FDA and other health authorities, including agency meetings
• Contribute to the development of integrated product development plans, target product profiles, timelines, and budgets
• Ensures key stakeholders, executive management, and project teams are appraised of developments that may impact regulatory success while exercising sound judgment and communicating in a timely and professional manner
• Effectively communicate regulatory strategy to the Executive team
• Reports to the Chief Development Officer
• Create functional strategies and specific objectives for the regulatory affairs department developing budgets, policies, and procedures to support the regulatory affairs infrastructure
• Responsible for the development, implementation, coordination, and monitoring of company programs to assure compliance with applicable regulatory requirements
• Guide establishment and implementation of standard operating procedures, processes, and best practices for regulatory compliance
• Manage regulatory affairs team members, including providing overall guidance, mentorship, coaching, and feedback and promote continuous professional development

Required Skills and Abilities:

• Expertise in strategic planning, risk management, and product development with current knowledge and understanding of US and International regulatory framework and regulations
• Current knowledge of and expertise in the interpretation of the US, ICH, and international regulations and guidelines and ability to apply the knowledge to problem solve and oversee programs in the product development lifecycle
• Excellent leadership skills and outstanding listening, written, and oral communication skills
• Proactive, strategic, and forward-thinking with the ability to analyze complex situations and propose solutions
• Proven ability to liaise with regulatory agencies in the US and internationally
• Proficiency in Microsoft Word, PowerPoint, some Excel

Education and Qualifications:

• 20+ years of experience in Regulatory Affairs the pharmaceutical or biotech industry or equivalent
• A degree in a scientific discipline required, advanced degree desirable
• Experience authoring and providing critical technical reviews of regulatory documents
• Experience building a regulatory affairs department including integration into a matrix structure and allocating resources to projects and/or programs
• In depth working knowledge of all aspects of drug development from pre-IND through Phase 4 clinical development. Commercial licensing and post approval experience is a plus

Our company

BioAge is a clinical-stage biopharmaceutical company harnessing the biology of human aging to develop new therapies for metabolic diseases. The Company’s human-first discovery platform analyzes proprietary multi-omics data captured over decades to identify molecular pathways that drive metabolic aging and disease. BioAge’s lead program, BGE-102, is a potent, orally available, brain-penetrant NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases. The Company is also advancing oral and injectable APJ agonists—exercise mimetics with the potential to enhance incretin-driven weight loss and restore healthy body composition in obesity. BioAge’s discovery platform is validated by ongoing research collaborations with Novartis and Lilly. BioAge has been listed on Nasdaq (BIOA) since 2024. For additional information about BioAge, visit the company’s website at https://bioagelabs.com.

Our workplace

BioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. Many positions (including this one) are remote, allowing our team members to work from anywhere. The salary for this role is expected to be approximately $300,000 - $350,000, depending on experience. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.

At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. 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.