Regulatory Affairs Manager

Regulatory Strategy & Lifecycle Management

Optimise regulatory strategies for new product registrations and changes to existing products.

Manage the lifecycle of the existing product portfolio, ensuring timely renewals and updates.

Coordinate and participate in the preparation of regulatory submissions to competent authorities.

Prepare and submit technical dossiers (ICH / CTD, ACTD format) and technical files to regulatory authorities.

Ensure proper compilation and submission of documents to NPRA, including responses to queries during NDA evaluations.

Maintain accurate reporting and ensure full compliance with regulatory requirements.

Review and approve product labelling for compliance with regional regulations.

Collaborate cross-functionally with R&D, Production, and QA departments.

Build and maintain credible relationships with national health authorities and external partners.

Provide regulatory insights and updates to internal teams on changes impacting operations.

Review scientific data to ensure completeness, accuracy, and alignment with program goals.

Stay up to date and act as a subject matter expert on local, ASEAN, ICH, and WHO regulatory requirements.

Lead regulatory risk assessments and mitigation planning.

Maintain regulatory databases and ensure accurate tracking of submission status and approvals.

Respond to ad-hoc regulatory requests and provide timely updates to senior management.

Support pharmacovigilance activities by managing drug safety documentation (e.g. RMP) and adverse reaction data.

Conduct safety trend analysis and maintain global safety databases.

Deliver safety training and assist in compliance and QA activities as needed.

Ensure validity of all licenses including company, product, and GMP certifications for external partners

Qualifications & Skills :

Candidate must possess of Bachelor’s Degree of Pharmacy, Science, Biotechnology or equivalent

Licensed pharmacist with Pharmacy board of Malaysia

Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance experience would be an advantage

An established candidate with a minimum of 5 years of experience in the Pharmaceutical industry

Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies

Have fluent oral and written communication skills in English

Distinct opportunity to build and be involved in the growth and evolution of the company

Promising opportunity to advance in an international company

Willing to work beyond office hours when needs arise

Unlock job insights

Your application will include the following questions :

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Regulatory Affairs Manager?
• Which of the following Microsoft Office products are you experienced with?
• Which of the following languages are you fluent in?
• Are you willing to travel for this role when required?
• How much notice are you required to give your current employer?

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