Manager – Regulatory Affairs
Posting Date: 14 Oct 2024 | Close Date: 12 Jan 2025
Client Background:Healthcare
Location:Shah Alam
Headcount:1
Tenure:Permanent
Remuneration:RM9,000-RM11,000
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 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.
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, 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 a bachelor's degree in pharmacy is a MUST.
Candidates with Senior RA experience and strong leadership skills is an added advantage.
Strong communication skills and the ability to manage the RA team.
If you are interested in this position, you may apply directly by clicking the "Apply" button or you may apply through our websitehttps://eps.my/jobseekers/ .Sub Specialization:Others; Any
Type of Employment:Permanent
Minimum Experience:5 Years
Work Location:Selangor#J-18808-Ljbffr