What are the responsibilities and job description for the Director Global Regulatory Affairs position at Barrington James?
About The Company
Our client is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies that address significant unmet medical needs. As the organization advances its pipeline through clinical development, we are seeking a skilled Global Regulatory Affairs Director to join the team and play a critical role in regulatory strategy and submissions.
Key Responsibilities
Our client is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies that address significant unmet medical needs. As the organization advances its pipeline through clinical development, we are seeking a skilled Global Regulatory Affairs Director to join the team and play a critical role in regulatory strategy and submissions.
Key Responsibilities
- Lead the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, and BLAs, in compliance with FDA and global regulatory requirements.
- Serve as the primary regulatory contact for assigned programs, providing guidance on regulatory pathways, timelines, and strategy.
- Manage communications and interactions with the FDA and other global health authorities, including meeting requests, briefing documents, and response letters.
- Support regulatory compliance activities including annual reports, safety updates, and post-approval submissions.
- 7 years of regulatory affairs experience in the pharmaceutical/biotech industry.
- Bachelor’s degree in biological or healthcare science.
- Proven experience leading FDA regulatory submissions (IND, NDA, BLA) through preparation, submission, and agency interaction
- Strong project management skills with the ability to work across teams in a fast-moving clinical environment.
- Experience with clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.