Regulatory Manager

📋 Description

• Provide regulatory guidance throughout the clinical development lifecycle, helping project teams
• Compile, coordinate, review, and support regulatory submissions, including INDs/CTAs, amendments
• Develop and review regulatory documents for submission to Regulatory Authorities and Ethics
• Represent Global Regulatory Affairs in internal and external project meetings, providing regulatory
• Lead regulatory projects or regional workstreams when required, coordinating activities, timelines
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets and maintain

🎯 Requirements

• Bachelor’s degree or equivalent professional experience, preferably in a scientific, healthcare, or
• At least 5 years of relevant Regulatory Affairs experience, ideally within a CRO or pharmaceutical
• Strong knowledge of the drug development process and associated regulatory milestones.
• Specialized regulatory experience in at least one major region, particularly the United States or
• Demonstrated understanding of clinical and pre-clinical study results and the ability to interpret
• Working knowledge of clinical trial methodology, including protocols, therapeutic indications, and

🎁 Benefits

• Base salary range of $106,000–$151,000 USD.
• Eligibility for a discretionary annual bonus.
• Health insurance coverage.
• Retirement savings benefits.
• Life insurance.
• Short-term and long-term disability benefits.