Executive Director, Head of Regulatory Affairs

Nature and Scope

The Executive Director, Head of Regulatory Affairs will be responsible for providing regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with US and global health authorities as needed to appropriately position American Regent’s product portfolio while also ensuring efficient and compliant internal regulatory operations. The position entails collaborating with key stakeholders to establish a comprehensive regulatory strategy from project initiation through development, filing, approval and launch for the company. The role will require multi-disciplinary activity and ability to build cross-functional collaboration with leaders from different departments and bring actionable leadership to American Regent.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• As a senior leader, contribute to the strategic planning process and function as the collective voice of Global Regulatory Affairs, working with the development leaders within ARMD and Manufacturing to develop a strong regulatory strategy and commercially viable launch strategy for company’s future growth.
• Ensure that all Chemistry, Manufacturing, and Controls (CMC) regulatory submissions meet global standards and facilitate the successful development, approval, and commercialization of the ARI Product portfolio.
• Ensure alignment of CMC regulatory strategies with broader regulatory, clinical, and commercial objectives to support timely development and registration of products.
• Manage the preparation, review, and submission of high-quality CMC regulatory documents for human and veterinary registrations in the US and globally.
• In alignment with organizational goals, develop and lead the implementation of regulatory strategies for American Regent products and compounds throughout all stages of clinical and commercial development, identifying and communicating regulatory risks.
• In close partnership with Development, provide high-level regulatory input to help develop complex generic, First to File (FTF) and First to Launch (FTL) parenteral products. Lead the preparation and submission of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational Drug (INDs) Applications, amendments, supplements, meeting requests, briefing packages, and other regulatory submissions in eCTD format in accordance with ICH, CFR, and current Regulatory Guidance for FDA submission. Support the development teams with appropriate FDA meetings and controlled correspondences.
• In close partnership with Development, provide high-level regulatory input to help develop New Animal Drug Application (NADA) and Abbreviated New Animal Drug Applications (ANADA). Support for these applications can include amendments, supplements, meeting requests, briefing packages, and other regulatory submissions in the requisite eCTD format (eSubmitter) and in accordance with applicable Regulation and guidance.

• Ensure that product regulatory history and correspondence is accurate and easily accessible to the product development teams for reference.

• In close partnership with Medical Team, provide strategic regulatory leadership for clinical development projects, including overall regulatory strategy, regulatory requirements for registration, and regulatory risk assessments and mitigations to ensure that all nonclinical and clinical programs (i.e. pharmacology, toxicology, and clinical trials) are appropriately informed and structured to meet regulatory requirements with a forward-looking mindset toward a product’s target product profile, and ultimate prescribing information. Effectively communicate required data to the FDA in eCTD or other required format in accordance with ICH, CFR, and current Regulatory Guidance for FDA submission eCTD format in accordance with FDA guidance’s.
• Serve as the Regulatory Thought Leader in Portfolio Management Committee meetings and for the development of New Drug Applications (NDAs), 505 (B) (2)s, Abbreviated New Drug Applications (ANDAs) and New Animal Drug Applications (NADAs).
• Assume strategic oversight of American Regent’s relationship with external collaborators like the Animal Health Institute.
• Establish and maintain effective relationships with regulatory agencies, especially the US Food and Drug Administration (FDA), EMEA, and Health Canada throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc.

• Lead Regulatory Due Diligence activities for any incoming BD opportunities.

• Harmonize submission dossiers across all manufacturing sites. Provide detailed mon