Associate Director Regulatory Affairs (Strategy)
Position Overview
We are seeking an experienced Regulatory Strategy professional to support global development and lifecycle management of innovative therapeutic and combination products. This role will provide strategic regulatory leadership across development programs and partner closely with cross-functional teams to enable successful interactions with health authorities and timely approvals.
Key Responsibilities
- Develop and execute global regulatory strategies across early and late-stage development, including lifecycle planning and labeling considerations.
- Serve as the regulatory strategy representative on cross-functional program teams, providing guidance on risk, timelines, and regulatory pathways.
- Lead preparation and review of regulatory submissions, briefing packages, and agency interaction materials.
- Support and participate in regulatory authority meetings (e.g., FDA, EMA), ensuring alignment between development plans and regulatory expectations.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- Significant regulatory affairs experience within biopharma, ideally including drug-device combination products or complex modalities.
- Demonstrated experience contributing to INDs, NDAs/BLAs, and global regulatory interactions.
- Strong communication skills with the ability to influence internal and external stakeholders.