Regulatory Affairs Specialist

2 weeks ago

Shah Alam, Malaysia Yes Health Sdn Bhd Full time

To prepare compilation of pharmaceutical product dossier submission to NPRA and follow through with subsequent correspondence until approval to formalize changes requiring regulatory submission initiated in the company.
- 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.
- Responsible for document submission to relevant 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.
- Coordinated and assist inter-department product information requests.
- To review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- 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 Requirements**:

- At least 1 year (s) of working experience in the related field is required for this position.
- Good Command of English and Bahasa Malaysia.
- 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.
- Self-motivated, meticulous, detail-oriented, able to multitask, and a good team player.
- **Fresh Graduates are welcome to apply.

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