Associate Director, Global Regulatory Strategy

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Oversee regulatory activities for both clinical and commercial registrations in global markets.

• Supervise overall regulatory management of the PSMA franchise, encompassing new product development, registration approvals, and lifecycle management.

• Formulate and execute regulatory strategies for INDs, NDAs, MAAs, and various other regulatory submissions.

• Lead the PSMA portfolio team, ensuring alignment of workloads, business objectives, and timelines.

• Direct registration strategies and processes in partnership with cross-functional teams.

• Serve as the regulatory lead for the PSMA portfolio across international regulatory frameworks.

• Provide assessments of regulatory risks along with mitigation strategies.

• Interact with applicants and health authorities, including the FDA, EMA, TGA Australia, CDE China, PMDA Japan, and other local entities.

• Collaborate with QA, Clinical Development, Research and Innovation, and other departments to guarantee timely and compliant submissions.

• Spearhead regulatory portfolio planning and prioritization.

• Advise senior management regarding regulatory risks and potential opportunities.

• Work alongside Commercial, Supply Chain, Quality, and Strategic teams.

• Oversee responses to inquiries from health authorities, variations, and post-market compliance obligations.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline (advanced degree preferred).

• Over 15 years of experience in Regulatory Affairs, including leadership roles.

• Extensive experience in clinical and commercial regulatory submissions, such as CTAs, INDs, NDAs, MAAs, and post-market variations.

• In-depth knowledge of global regulatory frameworks, including FDA, EMA, TGA, PMDA, Health Canada, and Medsafe.

• Proven track record of engaging with regulatory agencies and leading successful interactions with health authorities.

• Strong understanding of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle management.

• Capability to develop and implement global regulatory strategies.

• Proficient in managing cross-functional and regional teams.

• Excellent communication, collaboration, adaptability, ethical conduct, and commitment to continuous learning.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work options.