Barrington James Limited
Director Global Regulatory Affairs
Barrington James Limited, Oklahoma City, Oklahoma, United States
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
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. What We’re Looking For
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.
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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. What We’re Looking For
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.
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