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Regulatory Affairs Manager Needed in Shah Alam

RM 9,000 - RM 11,000 / Per Mon

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Job description:

  • 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.
  • 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

Hurry if you are the one we are seeking for kindly send your resume at this email [email protected] for a quick chat!!!

Job Types: Full-time, Permanent

Pay: RM9,000.00 - RM11,000.00 per month

Schedule:

  • Monday to Friday

Experience:

  • Auditing: 5 years (Required)