Regulatory Affairs

Intrinseque Health; Malacca City; On-site; MYR 50,000 - 70,000; Full time

Job summary

A healthcare company in Melaka Tengah is seeking a Regulatory Affairs professional for a full-time role. You will oversee the registration and compliance of pharmaceutical and medical device products, preparing regulatory documentation and collaborating with various teams. This role is crucial in navigating the regulatory landscape and ensuring compliance throughout the product lifecycle. Ideal candidates should have experience in regulatory affairs and excellent communication skills.

Responsibilities

• Preparing and submitting regulatory documentation for product registrations.
• Staying up-to-date with changes in regulatory requirements and guidelines.
• Collaborating with teams to ensure regulatory compliance.

Job description

Intrinseque Health is seeking a Regulatory Affairs professional to join our team in Melaka Tengah, Melaka. This is a full‑time position that will play a crucial role in ensuring our pharmaceutical and medical device products meet all relevant regulatory requirements and standards. As Regulatory Affairs, you will be responsible for overseeing the registration and compliance of our product portfolio, working closely with cross‑functional teams to navigate the complex regulatory landscape.

What you’ll be doing

• Preparing and submitting regulatory documentation for product registrations, variations and renewals
• Staying up‑to‑date with changes in local and international regulatory requirements and guidelines
• Collaborating with research & development, quality assurance and other teams to ensure regulatory compliance throughout the product lifecycle
• Providing regulatory guidance and support to internal stakeholders
• Serving as the primary point of contact for regulatory authorities
• Maintaining comprehensive regulatory records and databases
• Identifying and implementing process improvements to enhance regulatory efficiency