Regulatory Manager

7 days ago


Shah Alam, Selangor, Malaysia DCH Auriga (Malaysia) Sdn Bhd Full time

1. Regulatory services & Pharmacovigilance & handling of controlled drug

- Review and approve marketing and promotional materials to ensure compliance with relevant guidelines and standards.

- Manage registration processes and maintain an up-to-date database of sales and advertising permits issued by the appropriate regulatory authorities.

- 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

- Leads, plans, and directs the Regulatory Affairs (RA) team to ensure compliance with all applicable regulatory requirements. This includes, but is not limited to, conducting regulatory assessments, managing product registrations and notifications, and overseeing post-market obligations for all products imported and distributed by the Company.

- Poison License holder for the Company.

- Products Life Cycle maintenance in accordance to the regulations.

- Serves as the primary Pharmacovigilance Responsible Person, overseeing all post-market regulatory activities, including adverse event reporting, safety monitoring, and compliance with ongoing regulatory obligations.

- Ensure billings of regulatory related services are done correctly and timely

2. 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)

3. Training and business development

- Training in relevant regulations such as pharmacovigilance and complaints for sales and marketing team.

- Supports Commercial Departments in business development initiatives, including product evaluation, regulatory input during pre-launch planning, and ensuring alignment with market entry requirements.

- Represents the Company in pharmacy-related activities and engagements organized by relevant authorities and professional bodies, such as the National Pharmaceutical Regulatory Agency (NPRA), Medical Device Authority (MDA), and other industry institutions.

- Provides clinical product training to Sales & Marketing teams and targeted healthcare professionals (HCPs), ensuring accurate understanding of product features, usage, and regulatory considerations.

- Leads and manages medical and product-related enquiries, ensuring timely and accurate communication. Oversees educational initiatives and program support to enhance product knowledge and stakeholder engagement.



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