Regulatory Manager (Pharmaceutical Development)

Location: Remote, United States

Salary: $106,000–$151,000 USD annually, plus eligibility for a discretionary annual bonus.

Company

hirify.global provides clinical solutions and regulatory support for pharmaceutical development programs.

What you will do

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile, coordinate, and review submissions to Regulatory Authorities and Ethics Committees, including INDs, CTAs, amendments, annual reports, scientific advice requests, orphan designations, pediatric plans, and marketing applications.
• Develop and review regulatory documents for compliance with applicable standards and guidance.
• Represent Global Regulatory Affairs in internal and external project, client, and business development meetings.
• Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists to achieve submission targets.
• Maintain project plans, trackers, regulatory intelligence tools, quality initiatives, and regulatory training activities.

Requirements

• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
• At least 5 years of relevant regulatory affairs experience.
• In-depth knowledge of the drug development process, regulatory milestones, clinical trial methodology, and pharmaceutical regulations.
• Specialized regulatory knowledge for at least one major region, including the US or EU, covering INDs, CTAs, amendments, scientific advice procedures, and post-approval submissions.
• Ability to interpret clinical and pre-clinical study results for regulatory strategy and positions.
• Fluent English; availability for domestic and international travel, including overnight stays.

Nice to have

• Graduate or postgraduate degree.
• Basic understanding of financial management.
• Proficiency with Microsoft Office or Office 365.

Culture & Benefits

• Remote work environment with collaboration across internal and external project teams.
• Health insurance, retirement savings benefits, life insurance, and disability benefits.
• Parental leave and paid sick leave and vacation.
• Opportunities to contribute to continuous improvement, quality initiatives, and professional development.