Senior Manager, Global Regulatory Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the formulation and implementation of regulatory strategies for designated portfolio assets, ensuring they align with program objectives and global regulatory standards.

• Contribute to regulatory planning for the development of new products, global submissions, and lifecycle management activities across both pipeline and commercial assets.

• Collaborate cross-functionally to align regulatory strategies with clinical, CMC, and commercial initiatives.

• Stay informed about global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and incorporate them into program-level strategy and execution.

• Recognize regulatory risks and aid in the formulation of mitigation strategies in partnership with senior regulatory leadership.

• Lead preparations for interactions and submissions to Health Authorities, including the development of briefing documents, dossiers, and other required documentation in accordance with regulatory standards.

• Oversee responses to inquiries from Health Authorities and support the delivery of regulatory milestones.

• Ensure that documentation and communications are thorough, precise, and in alignment with the approved regulatory strategies.

• Act as the regulatory lead on assigned R&D project teams and collaborate across functions with Clinical, Quality, CMC, Commercial, non-clinical, and regulatory departments.

• Provide insights and recommendations regarding regulatory risks, opportunities, and implications for the global portfolio.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related scientific discipline is required.

• Over 8 years of experience in pharmaceuticals, biotech, or the life sciences field.

• At least 5 years of experience in Regulatory Affairs.

• A strong background in regulatory strategy for oncology or radiopharmaceutical products is highly preferred.

• Demonstrated experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE).

• Prior involvement with health authority interactions (briefing support, responses, documentation).

• Experience working in cross-functional teams (Clinical, CMC, Quality, etc.).

• A solid understanding of the drug development process and regulatory requirements throughout development and commercialization.

• Ability to interpret regulatory guidance and translate it into program-level actions.

• Strong project management and organizational skills, capable of managing multiple priorities effectively.

• Excellent collaborative and communication skills across functions.

• Capacity to identify risks and escalate issues appropriately, demonstrating sound judgment.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development