Our client, a well-established global pharmaceuticals company, is seeking an Assistant, Regulatory Affairs, Quality Assurance, and Pharmacovigilance to join their team. This role involves exposure to three functions, collaborating with regional members, providing legislative updates, ensuring regulatory compliance and training the internal team.
Main Responsibilities including:
- Staying informed about regulatory requirements, ensuring compliance, and communicating with global, regional, and local teams.
- Handling safety event reviews and submissions to both Global Pharmacovigilance and local health authorities.
- Managing registration dossiers for regulatory approvals and maintaining local licenses.
- Evaluating change requests and their regulatory impact.
- Reviewing product labeling for compliance with branding and regulations.
- Leading or supporting local Good Distribution Practice (GDP) inspections.
- Assisting in addressing deviations and product complaints while monitoring their resolution status.
Requirements:
- Degree in Pharmacy with minimum 1-2 years experiences in RA and/or QA in pharmaceutical industry. Malaysian licensed Pharmacist preferred.
- Strong organizational and process management skills. Able to multi-task effectively.
- Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
- Teamwork and collaboration with cross functional teams.