Senior Manager, Global Regulatory Strategy

Position Summary We are seeking a dynamic and experienced Senior Manager to provide essential support in developing and executing global regulatory strategies for investigational and marketed prescription drug submissions. You will manage the lifecycle activities of projects alongside the Global Regulatory Lead, while translating complex global requirements into actionable insights for project teams and business units. Job Responsibilities Develop and implement global regulatory strategies and manage submissions in collaboration with the Global Regulatory Lead. Conduct regulatory intelligence research and assess applicable precedent approvals to create strategic plans for assigned products. Assess and communicate regulatory challenges to various stakeholders, ensuring alignment across global regulatory teams. Collaborate with the global regulatory team and cross-functional partners to create comprehensive regulatory plans and respond to health authority queries. Prepare, review, and submit regulatory documents such as INDs, amendments, and NDAs within required timelines. Independently manage the preparation of regulatory submissions, ensuring compliance with guidelines. Verify the accuracy and quality of submission documents to facilitate timely approvals from regulatory authorities. Act as the primary point of contact between the organization and health authorities. Represent the Global Regulatory Affairs team in project meetings, providing essential regulatory guidance. Directly manage and support internal and external resources to meet project objectives. Interact with various departments to gather necessary data for timely submissions. Collaborate with the Global Regulatory Affairs department to enhance overall efficiency and productivity. Propose innovative ideas to address current and future challenges faced by the department. Knowledge, Skills, and Competencies Experience in the pharmaceutical or healthcare industry is essential. Proven knowledge of global regulatory submission processes (IND, CTA, NDA or BLA, MAA). RAC certification is a plus. Skills Excellent oral and written communication abilities. Strong understanding of drug development laws, regulations, and guidelines such as FDA and ICH. Adept at interpreting regulatory intelligence to enhance project outcomes. Proficient in leading teams and managing project scopes, timelines, and risks. Skilled at building effective relationships across functional teams to achieve business objectives. A results-driven and self-motivated professional with exceptional organizational skills, ready for growth and learning opportunities. Proficiency in Microsoft Office suite and familiarity with electronic document management systems (EDMS) is required. Physical Demands and Work Environment Willingness to travel approximately 20% of the time. Education and Experience A Bachelor's degree with at least 5 years of experience or a Master's degree with 2 years of experience in regulatory affairs or related fields (e.g., clinical development, project management, etc.) in the pharmaceutical or healthcare sector. Familiarity with regulatory interactions is preferred. Competencies Accountability for Results: Commitment to high performance standards and leading change. Strategic Thinking & Problem Solving: Long-term decision-making with consideration for diverse stakeholders. Patient & Customer Centricity: Ongoing focus on stakeholder needs. Impactful Communication: Clear communication that influences positive outcomes. Respectful Collaboration: Value diverse perspectives to achieve common goals. Empowered Development: Active role in professional development. Compensation ranges from $150,034.00 to $224,250.00, with additional incentive opportunities. Company Benefits: Enjoy comprehensive medical, dental, vision, and prescription drug coverage, life insurance, disability coverage, tuition reimbursement, generous 401(k) matching, flexible time off, holidays, and more. This job description provides a general overview and may be amended as necessary. We are an equal opportunity employer.

Created: 2026-03-04