Malaysia Job Openings
TERAJU PHARMA SDN BHD
Regulatory Affairs Senior Executive
FULL TIME
October 28, 2024
- Keep abreast with the updates in Drug Registration Guidance Document (DRGD) and relevant ASEAN guidelines.
- Ensure application for product re-registration is submitted within 6 months prior to the expiry of the validity period.
- Submit for variation applications to implement change to a pharmaceutical product and assist in the correspondence from the authority.
- Ensure supporting documents and responses by the Product Owner are submitted within the timeline stated in the Malaysian Variation Guideline.
- Assist to prepare relevant supporting documents, submit for renewal applications and reply to correspondences from the authorities.
- Conduct routine stock checks to prevent discrepancies in stock.
- Handle the Importation of Unregistered Controlled Substances.
- Assist the Quality & Regulatory Affairs, Senior Manager in ensuring internal and external audits are carried out in a smooth and efficient manner.
- Monitor the effectiveness of CAPA after implementation.
- To prepare, maintain and implement the necessary SOPs and other quality systems that meet the requirements of the regulations with respect to Good Distribution Practice (GDP) and Good Distribution Practice for Medical Devices (GDPMD).
- Ensure all regulatory approved requirements are implemented according to the timeline (i.e., product variation, hologram labels and labeling of registered medical devices).
- Monitor and document the process of complaints, ensure feedback is provided to the complainant according to the specified manner.
- Raise SCAR if related to product quality.
- Execute the product recall process with instructions from the local health authority or manufacturer, oversee and monitor the progress of product recall.
- Provide necessary correspondences and reports to NPRA.
- Adhere to the responsibilities for Local Responsible Person for Pharmacovigilance based on the Guidelines issued by NPRA.
- Oversee and manage all pharmacovigilance activities.
- Bachelor's degree in Food Science, Life Sciences, Nutrition, Pharmacy or any related field.
- Up to 2 years of related experience, or equivalent work experience.
- Experienced in QUEST3+ / Me DC@St 2.0+ Submissions.
- Have experience in healthcare industries would be an advantage.
- Proficiency in Microsoft Office Suite (Word, Excel, Power Point) and familiarity with office equipment.
- Excellent communication and problem-solving skills.
- Proficient in English and Bahasa Malaysia.
- Based in Teraju Pharma Sdn Bhd (Warehouse DC1) at Bandar Bukit Raja, Klang.
Pay: From RM3,600.00 per month
Benefits:
- Health insurance
- Maternity leave
- Parental leave
- Monday to Friday
- What is your expected salary?
- How long is your notice period?
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