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Jobs or company...

Manager Regulatory Affairs - Pharmacy

Salary undisclosed

Apply on

Indeed MY

Availability Status

This job is expected to be in high demand and may close soon. We’ll remove this job ad once it's closed.

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Position Title: Manager Regulatory Affairs

Location: Shah Alam, Selangor

Working Hour: Monday - Friday (8am - 5pm)

Responsibilities:

  • 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
  • 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
  • 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 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

Requirements:

  • Candidates with Senior RA experience and strong leadership skills could be considered for a Managerial position.
  • Degree in Pharmacy is a MUST
  • Strong communication skills and the ability to manage at least 3 team members in the RA team

Job Types: Full-time, Permanent

Benefits:

  • Cell phone reimbursement
  • Health insurance
  • Maternity leave
  • Opportunities for promotion
  • Parental leave
  • Professional development

Schedule:

  • Monday to Friday

Supplemental Pay:

  • Performance bonus

Application Question(s):

  • How much is your expected salary?
  • How long is your notice period?
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