Regulatory Manager

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.