Sr.Manager,GlobalRegulatoryStrategy

## Accountabilities Support the development and execution of global regulatory strategies across assigned pipeline and marketed products, ensuring alignment with clinical, CMC, and commercial objectives. Contribute to regulatory planning for product development, submissions, approvals, and lifecycle management activities across multiple regions. Assist in preparing health authority interactions, including briefing packages, submission dossiers, and response documents aligned with regulatory expectations. Support communication with regulatory agencies and help manage responses to questions, ensuring accuracy, consistency, and timely delivery. Identify regulatory risks and contribute to mitigation strategies in collaboration with senior regulatory leadership. Serve as a key contributor within cross-functional teams, ensuring regulatory considerations are embedded in development and commercialization plans. Coordinate with regional stakeholders to support execution of global regulatory strategies across different markets. Provide input on regulatory pathways, timelines, and strategic options to optimize development outcomes and market access potential. Requirements: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related scientific discipline (advanced degree preferred). 8+ years of experience in the pharmaceutical, biotech, or life sciences industry, including at least 5+ years in Regulatory Affairs. Strong experience supporting global regulatory strategies and working within international frameworks (FDA, EMA, TGA, PMDA, CDE). Demonstrated involvement in health authority interactions, including preparation of briefing materials and regulatory responses. Solid understanding of drug development processes across clinical development, CMC, and commercialization stages. Experience working effectively in cross-functional teams across R&D, quality, clinical, and commercial functions. Strong organizational and project management skills with