Global Regulatory Lead

Title: Associate Director Regulatory Affairs

A small but growing clinical stage company is seeking an Associate Director Regulatory Affairs to join the team in a remote capacity. They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space.

Responsibilites:

• Serves as regulatory affairs representative to provide input on global clinical trials, including coordination of health authority requests, filing activities, and ensuring that documentation and reporting systems are maintained and compliant.
• Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
• Contributes to the strategy for US FDA interactions with the cross-functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs.
• Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams.
• Supports US labeling development for NDA.
• Delivers regulatory achievements for assigned project(s), including the assessment of risks with mitigation strategies, emerging data, and the probability of regulatory success.
• Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals.
• Leads cross-functional teams, in partnership with global regulatory lead, to develop and execute regulatory strategies for assigned projects and programs.

Requirements/Key Attributes:

• Master's or above degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology, or comparable preferred; bachelor's degree in a scientific field required.
• 8+ years' experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred.
• Experience as direct contact with Major Health Authority desired.
• Previous experience in developing materials, attending, and supporting team preparation for Major Health Authority interactions.
• Strong experience with CTD format and content of regulatory filings for INDs, NDA/BLAs, MAAs, including developing strategy, writing, and reviewing documents.
• Strong organizational skills, ability to multi-task and manage workload independently.
• Detailed knowledge of regulatory drug development including product approval and maintenance.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Ability to work strategically within a business-critical and high-profile development program.
• Excellent verbal and written communication and presentation skills (English).
• Strong team player and ability to work across functions (matrix regulatory team).
• Comfortable in a small company environment that is fast-paced, challenging, and where all leaders must take a hands-on approach to get results.
• Excited and driven by science and the vision to improve disease management and patient care.