Full-Time Manager, Regulatory & Pharmacovigilance

Manager, Regulatory & Pharmacovigilance

Job Responsibilities

• Assume leadership and functional representation for projects of medium/high complexity, ensuring effective coordination and management of regulatory tasks, driving the team to meet targets and comply with procedures.
• Develop strategy and manage project setup (Project Management Plan, joint operating procedures, core documents) ensuring compliance with department standards.
• Support team members in preparing project strategy.
• Act as Local Contact Person for the designated country.
• Provide regulatory strategic input to internal and external customers, identifying and addressing risks.
• Problem-solve and resolve performance issues or delivery failures.
• Provide expert advice to clients addressing complex queries and regulatory changes.
• Set-up and coordinate a network of Local Contact Persons (LCPs) for RA and PV.
• Ensure correct training assignments and compliance for LCPs.
• Prepare client and vendor invoices.
• Provide training, coaching, and mentoring to junior staff.
• Foster professional relationships with internal/external contacts.
• Prepare/contribute to the Regulatory Newsletter and update the regulatory database.
• Ensure collection, QC review, and timely dissemination of regulatory intelligence.
• Support interpretation and impact analysis of legislation.
• Support client qualification activities.
• Ensure audit readiness and assign team members for audits.
• Provide responses to audit findings/follow-up questions.
• Contribute to vendor assessment and qualification, ensuring training and compliance with company standards.
• Support new business acquisition by participating in BDM activities.
• Develop and review regulatory sections of proposals.
• Drive departmental/company initiatives, managing changes (communication, timing, implementation).

Qualifications

• University degree in Biomedical/Natural/Health Sciences (Nursing, Pharmacy, scientific discipline).
• Experience in Pharmaceutical/CRO industry or Regulatory body, with proven experience in a leading/project management role.
• Proven ability to successfully manage global projects.
• Strong organizational and management skills.
• Excellent written and verbal communication.
• Strong interpersonal skills.
• Exceptional attention to detail.
• Proficiency in English.
• MS-Office proficiency (Word, Excel, PowerPoint).

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