Regulatory Affairs jobs in Saudi Arabia

Assist in regulatory affairs matters for DKSH Malaysia Sdn Bhd, Business Unit Healthcare.

• Assist in timely product registration and variation submission via NPRA Quest system for pharmaceutical products, including maintenance and document retention.
• Assist in timely product notification submission via NPRA Quest system for cosmetic products, including maintenance and document retention.
• Handle license application and maintenance.
• Manage permit applications and follow-up, staying updated on regulations in Malaysia.
• Liaise with local Regulatory Authorities to expedite approvals and serve as the official liaison with government agencies and the Ministry of Health.
• Ensure proper documentation of all regulatory applications and communications with clients and authorities.
• Ensure DKSH (M) operations comply with applicable laws and regulations.
• Ensure services align with RA agreements with clients.
• Review promotional materials to ensure compliance with Product Information, literature, PhAMA Code of Conduct, and authorities' guidelines.
• Act as Document Controller for the RA team.

• Knowledge of quality assurance tools, concepts, and methodologies.
• Understanding of Dangerous Goods Regulations and Safety Data Sheets (SDS).
• Basic understanding of the Global Harmonized System (GHS).
• Knowledge of local regulations and their applications.
• Proficiency in office tools like Excel, Word, and PowerPoint.
• Respect for cultural sensitivities in cross-cultural interactions.
• Fluency in the local language and preferably in English, both written and spoken.

• Bachelor's Degree in Pharmacy or related fields.