Our client is a clinical stage biotech dedicated to developing groundbreaking therapies to conquer unmet medical needs. They have a robust pipeline of technologies in early phase development and they are currently seeking an Associate Director/Director Regulatory Operations to join their growing team of industry leaders in the Autoimmune Disease space.
Summary:
- Lead the preparation and submission of regulatory filings, including CTAs, NDAs, INDs, and BLAs.
- Acts at the subject matter expert on US and global regulatory affairs
- Implements and organizes an Electronic Document Management platform
- Lead the preparation and submission of regulatory filings, including CTAs, NDAs, INDs, and variations/supplements.
- Oversee regulatory document preparation and review to ensure accuracy, completeness, and compliance with regulatory standards.
- Manage interactions with regulatory authorities during submissions and throughout product lifecycle.
- Manage relationships with external vendors, consultants, and CROs involved in regulatory activities.
Qualifications:
- Minimum of 10 years of progressive experience in regulatory affairs within the biopharmaceutical industry.
- BS, MS or PhD in a relevant scientific discipline
- Extensive experience in regulatory submissions (CTA, NDA, IND).
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).
- Proven leadership and management skills, with experience leading regulatory teams or projects.
