Manager – Regulatory Affairs
RM 9,000 - RM 11,000 / Per Mon
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Key Responsibilities:
- 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 post-market regulatory services.
- Ensure billings of regulatory related services are done correctly and timely
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)
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 pre-launch 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:
- Candidates must possess bachelor's degree in pharmacy is a MUST.
- Candidates with Senior RA experience and strong leadership skills is added advantage.
- Strong communication skills and the ability to manage RA team.
Job Types: Full-time, Permanent
Pay: RM9,000.00 - RM11,000.00 per month
Schedule:
- Monday to Friday
Education:
- Bachelor's (Preferred)
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