We 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.
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- Maintain 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.
[Apply now at https://my.hiredly.com/jobs/jobs-malaysia-polylab-biotech-sdn-bhd-job-regulatory-affairs-executive]
