Associate Director, Regulatory Operations

Role: Senior Regulatory Operations professional leading global regulatory submission planning, tracking, and process optimization for biopharma development programs. Responsibilities: develop and maintain integrated regulatory plans, ensure compliance with international requirements, partner with Regulatory Affairs to translate strategies into operational workflows within Veeva RIM, support health authority interactions, and lead system upgrades and process improvements. Qualifications: Bachelor's in life sciences, 8+ years in regulatory operations within pharma/biotech, strong expertise in global regulatory submission lifecycle management, and deep knowledge of Veeva RIM functionalities. HighValue: experience supporting multi-region submissions, regulatory data governance, and lifecycle management; familiarity with IND/NDA/BLA/MAA pathways; ability to lead cross-functional projects and support system validation. WorkSetup: typical office environment with approximately 10% travel; role involves collaboration with Regulatory, Clinical, Quality, and Pharmacovigilance teams.