Regulatory Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Manager based in United States.

This is an opportunity to play a key regulatory leadership role across the clinical development lifecycle.
You will provide strategic and operational regulatory guidance to support successful clinical programs and submissions.
The role combines hands-on submission management with cross-functional collaboration and regulatory strategy.
You will work closely with project teams, clients, Regulatory Authorities, and Ethics Committees to maintain quality and compliance.
The position offers exposure to complex pharmaceutical development activities across major regulatory regions.
You will also contribute to process improvement, regulatory intelligence, quality initiatives, and the development of other regulatory professionals.
Success in this role requires strong judgment, organization, communication, and the ability to independently drive multiple priorities forward.

Accountabilities:

• Provide regulatory guidance throughout the clinical development lifecycle, helping project teams navigate applicable regulations, guidance, milestones, and submission requirements.
• Compile, coordinate, review, and support regulatory submissions, including INDs/CTAs, amendments, annual reports, scientific advice and regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.
• Develop and review regulatory documents for submission to Regulatory Authorities and Ethics Committees, ensuring accuracy, completeness, quality, and compliance with applicable standards.
• Represent Global Regulatory Affairs in internal and external project meetings, providing regulatory expertise and strategic input to clients and cross-functional teams.
• Lead regulatory projects or regional workstreams when required, coordinating activities, timelines, deliverables, and stakeholder expectations.
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets and maintain effective execution across contracted programs.
• Maintain regulatory project plans, trackers, intelligence tools, and reporting mechanisms, keeping regulatory leadership informed of progress, risks, and upcoming milestones.
• Contribute to regulatory strategy, timeline development, business development opportunities, and the establishment of high-quality submission standards.
• Provide ICH GCP guidance, regulatory advice, and training to internal and external stakeholders as needed.
• Support corporate quality initiatives and continuous improvement efforts across clinical solutions and regulatory operations.
• Maintain current knowledge of pharmaceutical development regulations, laws, and guidance, translating relevant changes into practical recommendations for project teams.
• Participate in business development activities as a regulatory representative, supporting client discussions and new study opportunities.

Requirements:

• Bachelor’s degree or equivalent professional experience, preferably in a scientific, healthcare, or related discipline.
• At least 5 years of relevant Regulatory Affairs experience, ideally within a CRO or pharmaceutical environment.
• 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 European Union, including IND/CTA submissions, amendments, scientific advice procedures, and post-approval submissions.
• Demonstrated understanding of clinical and pre-clinical study results and the ability to interpret data in support of regulatory strategy and positioning.
• Working knowledge of clinical trial methodology, including protocols, therapeutic indications, and study requirements.
• Strong knowledge of regulations and guidance applicable to pharmaceutical development, including ICH GCP principles.
• Experience preparing, reviewing, and coordinating regulatory documentation with a strong focus on quality and compliance.
• Excellent written and verbal English communication skills, with the ability to present effectively to clients, colleagues, investigators, and other stakeholders.
• Strong interpersonal and collaboration skills, with the ability to influence and motivate project teams while balancing multiple priorities.
• Excellent organization, record-keeping, problem-solving, and time-management skills, with the ability to work independently and meet demanding deadlines.
• High level of professionalism, initiative, adaptability, and commitment to continuous improvement.
• Proficiency with Microsoft Office / Office 365 and general computer applications.
• Ability to manage varied assignments in a fast-paced environment with limited supervision.
• Availability for domestic and international travel, including occasional overnight stays.
• Graduate or postgraduate education and basic financial management knowledge are advantageous.

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.
• Parental leave.
• Paid time off, including vacation and sick leave.
• Remote work environment.
• Opportunities to contribute to professional development, regulatory strategy, and cross-functional initiatives.
• A collaborative environment with exposure to diverse clinical development programs and stakeholders.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1