Epicareer Might not Working Properly
Learn More

Manager – Regulatory Affairs (Healthcare)

Salary undisclosed

Apply on


Original
Simplified

1. Regulatory services & Pharmacovigilance & handling of controlled drug

• Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies.

• Responsible for the Regulatory Affairs (RA) functions and team members.

• Provide leadership and support to regulatory team in Malaysia.

• Represents RA as a member of the Leadership Team.

• Guides, plans, and directs the RA staff to create and/or maintain compliance to the applicable regulatory requirements, including but not limited to regulatory assessment, product registration, product notification and post market requirements for all products imported and distributed by DCH Auriga Malaysia.

• Acts as Poison License holder for the Company.

• Products Life Cycle maintenance in accordance with the regulations.

• Act as primary pharmacovigilance responsible person and other post-market regulatory services/activities (recall, product defect reporting).

• Ensure billings of regulatory related services are done correctly and timely.

2. Others

• Business compliance with local regulations and guideline.

• Product samplings by principals and regulatory agencies, as needed.

• Responsible for all related audits (Internal and External).

3. Training and business development

• Training in relevant regulations such as pharmacovigilance and complaints for commercial team.

• To support Commercial Departments in business development such as product evaluation and pre-launch activities.

• To represent the Company in pharmacy related activities organized by relevant societies or institutions.

• To support clinical product training to sales & marketing teams and targeted healthcare professionals (HCPs).

• To manage medical and/or product enquiries.

• To lead in medical communication and educational initiatives and program support.