Senior Regulatory Affairs Executive

JOB SUMMARY

Manage submission plan, prepare documents and execute all cosmetics, pharmaceuticals and medical devices regulatory activities in compliance with regulatory and legislative requirements to support timely and smooth launching of activities for marketing plan as well as sales of products.

KEY ACCOUNTABILITIES

1. Monitor and review the products’ licenses, registrations and documentation requirements are in proper order to ensure the company meets the regulatory requirements especially the new regulations.
2. Perform due diligence on the new products, potentially to be registered and provide regulatory impact to internal and external stakeholders.
3. Ensure proper documentation of all regulatory applications and communications with principals and authorities.
4. Manages end to end process of new product registration/ variation applications/ notifications for pharmaceuticals/ medical devices/ cosmetics in the selected territories the company operates in (i.e., MY/ SG/ PH).
5. Execute advertisement training activities to ensure relevant employees are updated on advertising guidelines and requirements.
6. Review and approve the promotional materials/ printed materials developed internally.
7. Prepare all documentation requirements in an accurate manner for product registration to ensure the Company meets the stipulated regulatory and legislative requirements of Malaysia & Singapore for timely approval.
8. Carry out administrative matters related to all product registration, licensing, compliance and queries to ensure they are in accordance to Ministry of Health regulations in Malaysia & Singapore.
9. Handle all queries from the Ministry of Health of Malaysia & Singapore to ensure accuracy of information is maintained.
10. Act as a local pharmacovigilance back-up in the absence of either the local RPPV and/ or Deputy RPPV to ensure critical pharmacovigilance activities (i.e., timely reporting of AE cases to principal and Health Authority) are conducted.

KEY CHALLENGES

• Ability to adhere to product registration timelines due to uncertainties during approval process by the regulatory agencies and authorities.
• Ability to comply with new regulations / amendments to regulations within grace period given.
• Managing and aligning expectations when dealing with the various principals/ internal stakeholders, especially when communicating/implementing regulatory agencies’ changes and guidelines.

KNOWLEDGE, SKILLS & EXPERIENCE

Knowledge

• Degree in Science or equivalent

Skills

• Registration of pharmaceutical products and medical device
• Renewal of product licenses and company licenses
• Review and approve promotional materials for the product

Experience

• 3 - 4 years’ experience in pharmaceutical product registration