![EPS Ventures Sdn Bhd](https://d10d02tod5sfve.cloudfront.net/poster-photo/default_image_company_gray.jpg)
Manager - Regulatory Affairs (Healthcare)
2 weeks ago
Key Responsibilities:
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.
- Poison License holder for the Company.
- Products Life Cycle maintenance in accordance to the regulations.
- Act as primary pharmacovigilance responsible person and other postmarket regulatory services.
- Ensure billings of regulatory related services are done correctly and timely.
2. Others
- Business compliance to local regulations and guideline
- Good distribution services.
- Advertisement and sales and marketing promotion of healthcare products.
- 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 sales and marketing team.
- To support Commercial Departments in business development such as product evaluation and prelaunch activities.
- To represent the Company in pharmacy related activities organized by relevant societies or institution such as NPRA, MDA and etc.
- 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.
Key Requirements:
- Minimum of 57 years of experience in regulatory affairs within the pharmaceutical.
Job Types:
Full-time, Permanent
Pay:
RM9, RM11,000.00 per month
Benefits:
- Cell phone reimbursement
- Health insurance
Schedule:
- Monday to Friday
Education:
- Bachelor's (preferred)
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