This job is perfect for someone who loves working in a regulatory environment. You might like this job because it involves managing product registrations, renewals, and dossier development.
RM 2600 - RM 3000
Full-Time
Job DescriptionWe are looking for an organised and detail-oriented problem solver who thrives in a dynamic, fast paced environment. As a Regulatory Affairs Executive, you will be responsible for all things regulatory including new product registration, product renewal, and dossier development.
Job RequirementsMaintain existing, and obtain new, regulatory approvals in support of the company's commercial activities and strategy.
Communicate with key stakeholders internally and externally, including with the Regulatory Authorities.
Keep up to date with regulatory legislation and guidelines in Malaysia and other ASEAN countries.
Prepare, compile, and submit a range of regulatory applications for pharmaceutical and traditional products.
Perform a review of current product information texts against updated Drug Registration Guidance Document to assess whether any changes are required.
Work with the Product Development Associate to create/update and implement approved artwork mock-ups via the QUEST 3+ Online Submission System.
Ensure accurate regulatory records are kept, electronic regulatory tracking database, electronic document management system, and management of the external archiving of regulatory documentation.
Provide regular updates to the Business Development Manager regarding the activities completed/projects planned and contribute to the monthly staff meetings.
Undertake general duties or projects as required by the business and the Business Development Manager.
SkillsAnalytical Skills
Data Analysis
Compliance Auditing
Teamwork
Regulatory Affairs
Regulatory Requirements
Regulatory Compliance
Experience Level0 - 3 Years of Experience
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