Sr. Manager, Global Regulatory Strategy in United States at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Manager, Global Regulatory Strategy based in the United States.
In this strategic and highly cross-functional role, you will help shape and execute global regulatory strategies that support both development-stage and marketed pharmaceutical products. You will contribute to advancing innovative therapies across oncology and rare diseases, ensuring alignment between regulatory pathways and broader clinical, CMC, and commercial objectives. Working closely with senior regulatory leadership, you will help prepare and support health authority interactions across multiple regions, including FDA, EMA, TGA, PMDA, and CDE. This role plays a key part in translating complex regulatory frameworks into actionable development plans that enable timely approvals and successful product lifecycles. You will operate in a fast-paced, global environment, collaborating with diverse stakeholders across R&D, quality, and commercial teams. The position is ideal for a regulatory professional passionate about precision medicine and improving outcomes for patients with high unmet medical needs.
- 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.
- 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 the ability to manage multiple priorities in a global environment.
- Excellent communication skills with the ability to translate regulatory requirements into clear, actionable plans.
- Strong analytical mindset with the ability to identify risks, escalate appropriately, and support decision-making.
- Oncology or radiopharmaceutical experience is highly desirable.
- Competitive compensation package including base salary, annual performance-based bonus, and equity incentives.
- Flexible hybrid and remote work arrangements across eligible locations.
- Generous paid time off, wellness days, and global holiday policies.
- Comprehensive health, dental, and vision insurance coverage.
- Learning and development support to encourage continuous professional growth.
- Opportunity to contribute to innovative therapies in oncology and rare diseases with global impact.
- Inclusive, collaborative, and mission-driven work environment.