Kaye/Bassman International
Senior Manager (or) Associate Director, Regulatory Operations
Kaye/Bassman International, Trenton, New Jersey, United States
Senior Manager (or) Associate Director, Regulatory Operations
Direct message the job poster from Kaye/Bassman International
Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International Hybrid Position
My client is a global clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs.
They are seeking a highly skilled and detail-oriented Senior Manager (or) Associate Director, Regulatory Operations to join their growing team. This individual will play a critical role in U.S. Biologics License Application (BLA) preparation, submission, and defense, while driving cross-functional collaboration and ensuring compliance with global regulatory standards.
This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.
Responsibilities
Lead project management and execution of major U.S. and global regulatory submissions (BLA, IND, MAA).
Develop and maintain comprehensive Global Submission Plans, timelines, and dossier tracking.
Coordinate publishing activities with external e-publishing vendors for all submission deliverables.
Manage all regulatory submission preparation and archiving activities within Veeva RIM.
Serve as a system expert supporting, training, and guiding users across regulatory and cross-functional teams.
Collaborate with partners across CMC, Clinical, Nonclinical, and Labeling to ensure timely, accurate submissions.
Support FDA Advisory Committee preparation and post-submission activities with Health Authorities.
Monitor regulatory intelligence and implement process improvements to enhance efficiency and compliance.
Qualifications
Must Have Proficiency in Veeva RIM – including document management, tracking regulatory commitments, and user training is required.
Bachelor’s degree in Life Sciences (advanced degree preferred).
5+ years of Regulatory Operations experience within biotech or pharmaceutical industries (biologics experience strongly preferred).
Proven success in preparing and submitting BLA and IND applications.
Deep understanding of global regulatory submission requirements and eCTD standards.
Experience supporting FDA Advisory Committee preparation preferred.
Strong communication, technical writing, and project management skills.
Referrals increase your chances of interviewing at Kaye/Bassman International by 2x
#J-18808-Ljbffr
Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International Hybrid Position
My client is a global clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs.
They are seeking a highly skilled and detail-oriented Senior Manager (or) Associate Director, Regulatory Operations to join their growing team. This individual will play a critical role in U.S. Biologics License Application (BLA) preparation, submission, and defense, while driving cross-functional collaboration and ensuring compliance with global regulatory standards.
This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.
Responsibilities
Lead project management and execution of major U.S. and global regulatory submissions (BLA, IND, MAA).
Develop and maintain comprehensive Global Submission Plans, timelines, and dossier tracking.
Coordinate publishing activities with external e-publishing vendors for all submission deliverables.
Manage all regulatory submission preparation and archiving activities within Veeva RIM.
Serve as a system expert supporting, training, and guiding users across regulatory and cross-functional teams.
Collaborate with partners across CMC, Clinical, Nonclinical, and Labeling to ensure timely, accurate submissions.
Support FDA Advisory Committee preparation and post-submission activities with Health Authorities.
Monitor regulatory intelligence and implement process improvements to enhance efficiency and compliance.
Qualifications
Must Have Proficiency in Veeva RIM – including document management, tracking regulatory commitments, and user training is required.
Bachelor’s degree in Life Sciences (advanced degree preferred).
5+ years of Regulatory Operations experience within biotech or pharmaceutical industries (biologics experience strongly preferred).
Proven success in preparing and submitting BLA and IND applications.
Deep understanding of global regulatory submission requirements and eCTD standards.
Experience supporting FDA Advisory Committee preparation preferred.
Strong communication, technical writing, and project management skills.
Referrals increase your chances of interviewing at Kaye/Bassman International by 2x
#J-18808-Ljbffr