Manager, Regulatory Registration and Compliance

About the role

PrimeVigilance is seeking a Manager to lead regulatory registration and compliance activities across global projects. The role combines strategic planning, project leadership and client interaction to ensure timely, high‑quality submissions that meet FDA, EMA and other health‑authority requirements.

Key responsibilities

• Develop and execute regulatory strategies and project plans in line with global requirements.
• Lead complex regulatory projects, coordinating internal teams and external partners to meet deadlines.
• Prepare, review and oversee submissions to FDA, EMA and other authorities, ensuring accuracy and compliance.
• Identify and mitigate regulatory risks, resolve issues and maintain adherence to company standards.
• Manage project resources, budgets and performance metrics.
• Support business development through proposal writing, budgeting and client engagements.
• Mentor and coach junior staff, providing training and guidance.
• Maintain client, partner and stakeholder relationships and monitor regulatory intelligence.

Required profile

• University degree in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology.
• Experience in pharmaceutical, CRO or regulatory environments, including leadership or project‑management roles.
• Strong knowledge of EU regulatory frameworks, ICH GCP/GVP and global pharmaceutical requirements.
• Excellent organizational and communication skills, with ability to manage multiple projects.
• Advanced written and spoken English.

Required skills

• Regulatory submissions to FDA, EMA and other health authorities.
• Regulatory intelligence monitoring and legislative updates.
• Knowledge of ICH GCP and GVP guidelines.
• Use of regulatory databases and dossier‑management software.
• Vendor qualification and performance oversight.