About the role
Vice President, Regulatory Affairs Vice President, Regulatory Affairs BioAge Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan. https://bioagelabs.com We are seeking an experienced VP of Regulatory Affairs to drive our regulatory strategy across our portfolio of products. 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