Regulatory Affairs Manager

My client is seeking a motivated Regulatory Affairs Manager to join their growing team. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution.

Key Responsibilities:

Regulatory Submissions

• Submission support : Prepare and deliver high-quality, timely regulatory submissions in compliance with applicable requirements.
• End-to-end ownership: Lead the creation, assembly, review, and archival of complex regulatory submissions requiring coordination across internal teams and CROs.
• Timeline management: Develop, manage, and track regulatory submission timelines to ensure on-time delivery.

Cross-Functional Collaboration

• Internal partnerships: Collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams to drive submission readiness.
• Site suppo rt: Review investigator packages and support site start-up activities from a regulatory perspective.
• Archive maintenan ce: Ensure submissions meet standards for accuracy, completeness, and consistency; maintain archives of health authority correspondence

Strategy & Compliance

• Regulatory intelligence : Analyze current regulatory issues, guidance, and initiatives; communicate regulatory intelligence effectively across the organizations.
• SOP development: Contribute to the development and review of standard operating procedures to ensure ongoing regulatory compliance.

Qualifications

• Degree: Bachelor's degree in a scientific or related field; advanced degree preferred.
• Experience: Minimum 6 to 8 years of regulatory affairs experience in pharmaceutical or biotechnology; advanced degree may be considered in combination with experience.
• Submission expertise: Demonstrated experience preparing regulatory submissions including INDs, DSURs, CTAs, and FDA meeting requests.
• Communication: Strong interpersonal and collaboration skills across internal and external stakeholders.
• Project management: Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment.
• Attention to de t ail : Excellent analytical thinking and problem-solving abilities; close attention to accuracy and consistency.
• Writing : Excellent writing and editorial skills; ability to develop high-quality clinical-regulatory documents such as investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests.
• Scientific acumen : Strong scientific foundation with the ability to quickly acquire knowledge in new therapeutic areas and the evolving regulatory landscape.
• Regulatory knowledge: Familiarity with FDA and ICH guidelines; motivated to gather and apply current regulatory intelligence.
• Sys t ems: Proficiency in Microsoft Office Suite; experience with Veeva RIM a plus.