Manager, Regulatory Affairs - GDP
About The Position
The Manager, Regulatory Affairs – Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects, owning regulatory deliverables and acting as a key point of contact for cross-functional teams. The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and escalates as needed to support successful regulatory outcomes.
Requirements
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Experience supporting US regulatory drug development activities based on FDA and ICH requirements.
- Demonstrated experience supporting or leading components of regulatory submissions (e.g., INDs, NDAs) and lifecycle management activities in alignment with FDA and ICH requirements
- Experience preparing and maintaining regulatory submissions and source documentation; familiarity with publishing/QC processes.
- Ability to independently manage regulatory deliverables from planning through submission, ensuring timely, high-quality outcomes with minimal oversight
- Comfortable operating in a fast-paced environment with evolving priorities, applying regulatory knowledge to adapt and respond effectively
- Drives alignment and progress across teams without direct authority, effectively partnering with stakeholders to achieve regulatory objectives
- Maintains high standards for accuracy, completeness, and compliance across all regulatory deliverables
- Identifies risks early, applies sound judgment, and takes appropriate action or escalation to resolve issues
- Clearly communicates regulatory considerations, risks, and timelines to cross-functional stakeholders, including presenting to study and project teams as needed
- Ability to manage multiple priorities with strong attention to detail while meeting established timelines
Responsibilities
- Serve as the Regulatory Affairs lead for assigned clinical programs and submissions, acting as the primary point of contact for regulatory activities
- Lead preparation, organization, and QC review of regulatory submissions (e.g., INDs, NDAs, amendments, supplements)
- Manage submissions end-to-end, from planning through publishing and final delivery in partnership with Regulatory Operations
- Own and drive regulatory deliverables, ensuring alignment with timelines, quality standards, and regulatory requirements
- Contribute to the development and execution of regulatory strategies for assigned programs, applying regulatory knowledge and critical thinking
- Interpret regulatory requirements and assess their impact on study design, submissions, and documentation
- Identify regulatory risks, support development of mitigation strategies, and drive issue resolution or escalation as needed
- Lead and/or facilitate cross-functional alignment and provide regulatory guidance to ensure consistency, accuracy, and compliance across deliverables
- Represent Regulatory Affairs on cross-functional teams, clearly communicating regulatory considerations, timelines, and risks to stakeholders
Benefits
- comprehensive benefits
- bonus
- long-term incentive
- applicable allowances
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What This Job Offers
Job Type
Full-time
Career Level
Manager
