Associate Director of Regulatory Affairs

A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval compliance for a diverse portfolio of pharmaceutical products. This is a unique opportunity to join a purpose-driven organization focused on delivering better health outcomes through innovation, collaboration, and regulatory excellence.

The Associate Director main responsibilities will be…

• Develop and implement regulatory strategies for assigned BRANDED/PRESCRIPTION pharmaceutical products, including NDA, ANDA, BLA, OTC, and device categories.
• Serve as a regulatory lead on cross-functional product development and life-cycle management teams.
• Ensure timely and accurate preparation of regulatory submissions and responses to health authorities.
• Collaborate with global regulatory counterparts to ensure regional compliance and integration into product strategies.
• Support the development and maintenance of compliant product labeling in coordination with labeling leads.
• Act as a primary contact with regulatory agencies and support inspections and audits.
• Provide regulatory input for business development and due diligence activities.
• Contribute to annual planning and budgeting for regulatory activities.
• May manage or mentor junior regulatory staff.

The Associate Director must have the following qualifications:

• Bachelor's degree in a science or health-related field required; advanced degree preferred.
• Minimum of 6 years of regulatory affairs experience in the pharmaceutical industry, with strong knowledge of BRANDED/PRESCRIPTION product regulations.
• Experience across the product life-cycle, including development, labeling, advertising/promotion, and compliance.
• Familiarity with domestic and international regulatory frameworks.
• Ability to interpret and apply regulatory guidance to product strategy and documentation.
• Regulatory Affairs Certification (RAC) is a plus.