Role Purpose
To act as the designated Regulatory Pharmacist, responsible for ensuring compliance with all the applicable regulatory requirements, including product registration, licensing and post-marketing obligations.
Key Responsibilities:
- Act as the regulatory pharmacist for regulatory compliance matters
- Oversee and ensure timely renewal of licenses and permits
- Prepare and/or review product registration submissions to relevant authorities (e.g. MDA)
- Liaise directly with regulatory authorities and manage queries, responses and follow-ups
- Ensure all regulatory documentation is accurate, complete and compliant
- Maintain oversight of importation requirement and regulatory compliance processes
- Keep the company updated on changes in regulatory guidelines and requirements
- Provide professional input and sign-off where required
Key Responsibilities:
- Registered Pharmacist with a valid Annual Practicing Certificate (APC) in Malaysia
- Familiar with regulatory affairs, product registration, licensing
- Familiar with MDA requirements
- Strong communication and communication skills
Engagement Terms
- Retainer/part-time-based with defined scope of responsibilities
- Availability for regulatory matters and authority interactions as required
