Job Responsibilities:
- 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.
Your Requirements:
- Degree in Pharmacy with minimum 1-2 years experiences in RA and/or PV 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.
- Excellent verbal and written communication skills in English.