Regulatory Affairs Specialist

A leading pharmaceutical organisation in Kuala Lumpur is seeking a Regulatory Affairs Specialist to join their Regulatory Affairs team. This pivotal role offers you the opportunity to shape regulatory strategy, ensure compliance with Malaysian pharmaceutical regulations, and support product registration and lifecycle management. You will play a crucial part in supporting new product launches, managing life cycle activities, and ensuring corporate compliance with local authorities.

What you'll do:

As a Regulatory Affairs Specialist based in Kuala Lumpur within the Regulatory Affairs department, you will be responsible for driving regulatory strategy across multiple pharmaceutical products. Your day-to-day activities will involve preparing detailed submissions for new drug applications as well as variations and renewals. You will manage labelling updates and post-approval changes using ASEAN CTD dossiers alongside e-Submission platforms. Ensuring timely submission according to NPRA requirements is essential for success in this role. You will also maintain continuous inspection readiness by supporting both external NPRA audits and internal evaluations. Addressing deficiencies quickly through corrective actions is key to maintaining compliance. Building collaborative relationships with authorities such as NPRA and Pharmacy Board of Malaysia forms an integral part of your responsibilities. Acting as the company spokesperson during meetings or site visits allows you to represent organisational interests effectively. Maintaining meticulous documentation ensures that all files are up-to-date according to global SOPs. Supporting new product launches requires strategic insight into Malaysian healthcare regulations while monitoring changes in local laws keeps your team informed. Your expertise will guide cross-functional teams through complex regulatory landscapes so that every product meets legal requirements throughout its lifecycle.

• Lead comprehensive submissions for new drug applications, variations, renewals, labelling updates, and post-approval changes by overseeing preparation of ASEAN CTD dossiers and managing e-Submission platforms.
• Ensure timely and accurate regulatory submissions according to NPRA requirements for biologics, generics, or combination products while maintaining up-to-date knowledge of evolving guidelines.
• Maintain continuous inspection readiness by supporting NPRA audits, internal audits, distributor evaluations; address deficiencies promptly and implement corrective and preventive actions (CAPA) to safeguard compliance.
• Build collaborative relationships with NPRA, Pharmacy Board of Malaysia, Ministry of Health (MOH), and other relevant stakeholders in the regulatory and market access space to facilitate smooth communication.
• Act as the company spokesperson during regulatory meetings, site visits, audits; represent organisational interests professionally while providing clear information to authorities.
• Maintain meticulous regulatory files including correspondence, licenses, approval letters in accordance with global SOPs and local standards to ensure seamless document management.
• Support new product launches by coordinating regulatory strategies that align with business objectives while ensuring all legal requirements are met throughout the product lifecycle.
• Provide expert guidance on Malaysian regulatory frameworks including NPRA guidelines and ASEAN harmonisation to internal teams for effective cross-functional collaboration.
• Monitor changes in local regulations affecting pharmaceutical products; proactively communicate updates to relevant departments to ensure ongoing compliance.
• Contribute to audit preparedness by developing robust processes for inspection readiness; participate actively in internal reviews to identify areas for improvement.

What you bring:

The ideal candidate for the Regulatory Affairs Specialist role brings substantial experience from the pharmaceutical sector—preferably two to three years—demonstrating proficiency in navigating complex regulatory submissions. If you have additional exposure to MedTech or medical device regulation it will further enhance your suitability for this position. Your background as a Responsible Pharmacist or involvement in regulatory-compliance roles equips you with practical insights into Malaysian frameworks like NPRA guidelines and ASEAN harmonisation principles. Exceptional communication skills enable you to negotiate effectively with authorities while fostering positive relationships internally. Leadership combined with project management capabilities ensures efficient coordination across multiple projects involving various departments. A detail-oriented mindset guarantees accuracy when handling documentation related to product registrations or lifecycle management. Your sound judgment supports proactive risk management strategies that protect organisational interests during audits or inspections. Familiarity with MS Office tools plus experience using submission systems such as NPRA QUEST or eCTD tools streamlines your workflow. Working independently yet thriving within multicultural teams highlights your adaptability—a quality highly valued by this organisation.

• Preferably 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry demonstrating proven capability in handling complex submissions.
• Experience in MedTech or medical device regulation is considered an added advantage for candidates looking to broaden their impact.
• Proven track record as a Responsible Pharmacist or experience in a regulatory-compliance capacity is essential for this position.
• Strong knowledge of Malaysian regulatory frameworks including NPRA guidelines and ASEAN harmonisation principles is required.
• Excellent communication skills enabling effective negotiation with regulatory authorities as well as internal stakeholders across departments.
• Leadership qualities combined with project management skills allow you to coordinate multiple tasks efficiently within cross-functional teams.
• Detail-oriented approach ensures high standards for accuracy when preparing documents or managing data related to product registrations.
• Sound judgment coupled with decision-making abilities helps manage regulatory risks proactively while safeguarding organisational interests.
• Proficiency in MS Office tools along with familiarity using regulatory submission systems such as NPRA QUEST or eCTD tools is necessary.
• Ability to work independently yet thrive within multicultural environments fosters successful collaboration across diverse teams.

What sets this company apart:

This organisation stands out due to its commitment towards nurturing talent within a supportive leadership framework that prioritises professional development through generous training opportunities. Employees benefit from flexible working arrangements designed to accommodate personal needs while promoting work-life balance. The company’s inclusive culture welcomes individuals from diverse backgrounds fostering an environment where collaboration thrives across cross-functional teams. With a focus on continual learning employees are encouraged to expand their skillsets through structured programmes tailored towards career advancement within the pharmaceutical industry. The leadership team is dedicated not only to achieving business goals but also ensuring each employee feels valued respected and empowered throughout their journey here.

What's next:

If you are ready to make a meaningful impact on pharmaceutical regulation in Malaysia apply now for this exciting opportunity!

Apply today by clicking on the link provided.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C