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:
Bachelor\'s Degree in Pharmacy, Life Sciences or equivalent with minimum 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.