Manager, Regulatory Affairs

Accountabilities

• Lead and coordinate regulatory and ethics committee submissions and maintain required approvals across EMEA, Asia Pacific, and Latin America.
• Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained in accordance with applicable requirements and timelines.
• Provide expert regulatory guidance throughout clinical research projects and advise stakeholders on country-specific and international regulatory requirements.
• Review and provide recommendations on technical and study documentation, including IMPDs, IBs, and other relevant materials, to ensure alignment with ICH GCP and applicable country requirements.
• Communicate submission status, timelines, risks, and regulatory considerations effectively with sponsors, Project Managers, CRAs, and Medical & Scientific Affairs teams.
• Support business development activities by reviewing study budgets and costing, contributing to contract negotiations, preparing regulatory sections of proposals and feasibility reports, and participating in bid defense meetings.
• Contribute to broader regulatory project activities and provide strategic input to support study and business objectives.
• Train, coach, and mentor junior regulatory affairs professionals and, where required, provide direct line management.

Requirements:

• Bachelor's degree or equivalent four-year college education with a major concentration in medical, biological, physical, health, pharmacy, or another relevant scientific discipline.
• Alternatively, a two-year college qualification or equivalent education/training, such as a nursing or life sciences degree, combined with at least eight years of clinical research experience, including areas such as Clinical Research Associate or Regulatory Affairs roles.
• Minimum 5–7 years of experience within the pharmaceutical or CRO industry, with demonstrated senior-level regulatory affairs or clinical start-up experience.
• Proven leadership, organizational management, planning, strategic thinking, scheduling, monitoring, and critical evaluation skills.
• Strong understanding of regulatory processes and clinical research requirements, with the ability to interpret and apply ICH GCP and country-specific regulations.
• Excellent written and verbal English communication skills, with the ability to present complex information clearly and concisely.
• Strong interpersonal and relationship-building skills, including confidence supporting business development activities and face-to-face client meetings.
• Demonstrated ability to collaborate effectively across cultures and geographies.
• Ability to manage multiple priorities, meet deadlines, and remain effective in a fast-paced and continuously changing environment.

Benefits:

• Opportunity to work in an international clinical research and regulatory affairs environment.
• Exposure to regulatory activities across EMEA, Asia Pacific, and Latin America.
• Opportunities for professional development, coaching, and leadership growth.
• Collaborative and supportive working environment focused on innovation and high-quality clinical research.
• Opportunity to contribute to programs supporting the development of innovative medical products.
• Inclusive workplace culture that values diverse backgrounds, perspectives, collaboration, and creativity.
• Additional compensation, healthcare, flexibility, and other employment benefits may be provided according to the local employment package and applicable company policies.