Executive, Regulatory Affairs
1 week ago
**Responsibilities and Duties**:
- To prepare compilation of pharmaceutical product dossier for variation submission to NPRA and follow through with subsequent correspondence till approval to formalize changes requiring regulatory submission initiated in the company.
- To assist and be involved in the company’s Halal compliance activity and initiatives including internal and/ or external audit and training.
- To be the person in charge/coordinator for variation related activities in the department. Responsible to ensure full adherence to variation submission procedures including monthly report generation, maintenance of tracker, etc.
- To be the person in charge of all government tender/APPL related matters
- Responsible for Bio-Equivalence (BE) submission to regulatory authorities, and attending to related queries i.e. both from internal and external sources
- To assist in preparing the relevant departmental processes in standard operating procedures, work instructions.
- To keep updated on current regulatory requirements as and when it is made available by the regulatory authorities.
- To coordinate and assist inter-department product information requests.
- To assist superior to participate in all projects undertaken by the team intra and inter-departmental where required
- Any other duties that may be assigned by Management from time to time.
**Job Specifications**:
- At least 3 years (s) of working experience in the related field is required for this position.
- Proficient with NPRA Quest3+, MS Office, and relevant regulatory system software.
- Effective management skills in retrieving information for supporting regulatory activities and comprehending guidelines and requirements.
**Salary**: RM3,500.00 - RM5,000.00 per month
**Benefits**:
- Additional leave
- Dental insurance
- Flexible schedule
- Free parking
- Health insurance
- Maternity leave
- Meal allowance
- Opportunities for promotion
- Parental leave
- Professional development
- Vision insurance
- Work from home
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Klang: Reliably commute or planning to relocate before starting work (required)
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