Executive, Regulatory Affairs

DKSH Group; Petaling Jaya; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player in healthcare seeks a dedicated individual to assist in regulatory affairs. This role involves managing product registrations, liaising with local authorities, and ensuring compliance with regulations. The ideal candidate will have a Bachelor's Degree in Pharmacy, strong knowledge of regulatory processes, and proficiency in office tools. Join a forward-thinking company where your contributions will help shape the future of healthcare in Malaysia, ensuring that products meet all regulatory requirements while respecting cultural sensitivities.

Qualifications

• Bachelor's Degree in Pharmacy or related fields is required.
• Knowledge of quality assurance tools and local regulations.

Responsibilities

• Assist in product registration and variation submissions via NPRA Quest system.
• Liaise with local Regulatory Authorities for approvals and compliance.
• Ensure documentation of all regulatory applications and communications.

Skills

Regulatory Affairs Knowledge

Quality Assurance Tools

Dangerous Goods Regulations

Safety Data Sheets (SDS)

Office Tools Proficiency (Excel, Word, PowerPoint)

Cultural Sensitivity

Fluency in Local Language

Fluency in English

Education

Bachelor's Degree in Pharmacy or related fields

Job description

Assist Senior Pharmacist, Regulatory Affairs

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

General Responsibilities

• 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.

Functional Skills and Knowledge

• 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.

Education

• Bachelor's Degree in Pharmacy or related fields.