Senior Regulatory Affairs Specialist

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We are looking for a passionate individual to join the team to cope with our business expansion. Under the overall direction and guidance of the Regional Business Director, Asia; the responsibilities include but are not limited to the following:

• Handling regulatory submissions, and working closely with regulatory agencies such as the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia and trade associations, ensuring that the company adheres to all local and international laws, regulations, and standards.
• Review, compile, and submit NDAs for pharmaceutical products to the local regulatory authorities, following local regulations and international formats such as ICH and ACTD.
• Ensure regulatory compliance and support license renewals, safety reports, for the existing product portfolio.
• Coordinate with stakeholders regarding the registration dossiers and ensure their compliance with NPRA registration.
• Track the status of submissions and manage the queries raised during evaluations.
• Maintain databases for licenses, certificates, and other important documents related to the products and product registrations.
• Stay up to date with regulation updates in the local market, access their impacts on the company and provide insights to internal stakeholders.
• Perform any other ad-hoc duties as assigned.

Job Highlights

• Work from home arrangement
• Salary commensurate with experience
• A collaborative company culture
• Able to start work as soon as possible

Job Requirements

• Bachelor’s degree in Life Sciences, Pharmaceutical or other equivalent/related field.
• Minimum 5 years work experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge in pharmaceutical regulatory processes and regulations, guidelines, and international regulatory standards.
• Proven track record of successful product registrations and interactions with regulatory agencies.
• Competence in collaborating with colleagues/stakeholders across different regions and functional teams.
• Ability to work autonomously and independently with good time management skills.
• Attention to detail and proficiency in using regulatory systems and databases.
• Excellent verbal and written communication skills in English and Bahasa Malaysia.
• Proficient in MS Office.

Only shortlisted candidates will be contacted. Personal data provided will be treated in strict confidence and used for recruitment purposes only.

About Tranet Group

With more than 30 years of expertise, Tranet Group is a multinational pharmaceutical distribution company with a global presence, primarily in Asia. Our main goal is to provide ambulatory care units, hospitals, and pharmacies with high quality and cost-effective medications.

Over the years, we have partnered with several leading manufacturers and suppliers which has enabled us to deliver an extensive array of superior products to our customers while adhering to ethical business standards.

Headquartered in Austria and Singapore, Tranet Group has regional footprints in many countries including Hong Kong, Vietnam, Cambodia, Myanmar, and more to come.

Our network and track record of success has also empowered us to advance our current laboratory services project, including biopharmaceutical research and development in Vietnam.

At Tranet Group, we take pride in our capacity to grow sustainably and our dedication to forging enduring bonds with our partners.