Senior Regulatory Affairs Executive

EP Plus Group; Kuala Lumpur; On-site; MYR 60,000 - 80,000; Full time

Job summary

A regional healthcare corporation in Kuala Lumpur seeks a professional to manage submission plans and regulatory activities for pharmaceutical products. The ideal candidate will have a degree in Science and 3-4 years of experience in product registration. Responsibilities include monitoring licenses, ensuring compliance with health regulations in Malaysia & Singapore, and collaborating with internal stakeholders. The role offers an opportunity to be part of a leading corporation dedicated to healthcare solutions.

Qualifications

• 3-4 years' experience in pharmaceutical product registration.

Responsibilities

• Manage submission plan and execute regulatory activities.
• Monitor product licenses and documentation requirements.
• Ensure documentation accuracy for product registration.

Skills

Registration of pharmaceutical products and medical device

Renewal of product licenses and company licenses

Review and approve promotional materials for the product

Education

Degree in Science or equivalent

Job description

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

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.

Perform due diligence on the new products, potentially to be registered and provide regulatory impact to internal and external stakeholders.

Ensure proper documentation of all regulatory applications and communications with principals and authorities.

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).

Execute advertisement training activities to ensure relevant employees are updated on advertising guidelines and requirements.

Review and approve the promotional materials/printed materials developed internally.

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.

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.

Handle all queries from the Ministry of Health of Malaysia & Singapore to ensure accuracy of information is maintained.

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.

EP Plus Group is a regional healthcare corporation headquartered in Malaysia, with a strong presence in Singapore, Indonesia, and the Philippines. With over 27 years of experience, we build and grow brands into market leaders through our business units – Pharmaceuticals, Fertility Sciences, Medical Aesthetics, and Medical Nutrition. Committed to innovating for better lives, we bring cutting‑edge healthcare solutions to patients across Southeast Asia.