Manager - Regulatory Affairs (Healthcare)

2 weeks ago


Shah Alam, Selangor, Malaysia EPS Ventures Sdn Bhd Full time

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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