Our client, a growing organization within the pharmaceutical and healthcare sector, is seeking to recruit a competent and detail-oriented Regulatory & Pharmacovigilance Specialist to support regulatory compliance, product safety monitoring, and adherence to pharmaceutical industry standards.

The successful candidate will be responsible for managing regulatory submissions, maintaining compliance with regulatory requirements, and supporting pharmacovigilance activities to ensure the safety, quality, and effectiveness of pharmaceutical products.

Key Responsibilities

Regulatory Affairs

• Prepare, review, and submit regulatory documentation to relevant regulatory authorities.
• Support product registration, renewals, variations, and regulatory compliance activities.
• Maintain accurate regulatory records, databases, and documentation.
• Monitor changes in regulatory requirements and advise the business on compliance implications.
• Liaise with regulatory authorities and internal stakeholders on regulatory matters.
• Ensure all products and processes remain compliant with applicable pharmaceutical regulations.

Pharmacovigilance

• Support the implementation of pharmacovigilance systems and procedures.
• Receive, review, document, and report adverse drug reactions and safety information.
• Conduct follow-ups on safety reports and ensure timely submission of required documentation.
• Maintain pharmacovigilance records and safety databases.
• Support preparation of pharmacovigilance reports and compliance documentation.
• Ensure adherence to pharmacovigilance guidelines and industry best practices.

Qualifications & Experience

• Bachelor’s Degree in Pharmacy from a recognized institution.
• Registered with the relevant professional regulatory body.
• Minimum of two (2) years’ experience working in both Regulatory Affairs and Pharmacovigilance within the pharmaceutical, healthcare, or related industry.
• Good understanding of pharmaceutical regulatory requirements and pharmacovigilance practices.
• Experience in regulatory submissions, product registrations, safety reporting, and compliance documentation.
• Strong attention to detail, analytical ability, and excellent documentation skills.
• Ability to work independently while collaborating effectively with cross-functional teams.