Regulatory Affairs Senior Executive

TERAJU PHARMA Sdn Bhd; Klang City; On-site; MYR 200,000 - 250,000; Full time

Job summary

A pharmaceutical company in Klang City is seeking a qualified candidate for regulatory compliance roles, including maintenance of product registration and handling audits. Responsibilities include monitoring product complaints and executing recalls. Candidates should possess a Bachelor’s degree in a relevant field and up to 2 years of related experience. Proficiency in Microsoft Office and languages is required. Immediate starters preferred.

Qualifications

• Up to 2 years of related experience or equivalent work experience.
• Experience in healthcare industries would be an advantage.

Responsibilities

• Maintain and ensure product registration validity.
• Submit for product variation and change notifications.
• Assist in license and certificate applications.
• Handle psychotropic and dangerous drugs documentation.
• Assist with internal and external audits.
• Prepare and implement necessary SOPs.
• Ensure all regulatory requirements are met.
• Monitor product and customer complaints.
• Execute product recall processes.

Skills

Excellent communication

Problem-solving skills

Proficient in English

Proficient in Bahasa Malaysia

Proficiency in Microsoft Office Suite

Education

Bachelor's degree in Food Science, Life Sciences, Nutrition, Pharmacy or related field

Tools

QUEST3+

MeDC@St 2.0+

Job description

JD 1 - Maintenance of Product Registration Validity

Keep abreast with the updates in Drug Registration Guidance Document (DRGD), Medical Device Authority (MDA and relevant ASEAN guidelines.

Ensure application for product re-registration is submitted within 6 months prior to the expiry of the validity period.

JD 2 – Product Variation and Change Notification Submissions

Submit for variation applications to implement change to a pharmaceutical product and change notification for medical devices, following with 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 and Change Notification Guideline.

JD 3 – License, Certificate Application and Renewal

Assist to prepare relevant supporting documents, submit for renewal applications and reply to correspondences from the authorities.

JD 4 – Handling of Psychotropic and Dangerous Drugs

Prepare and submit documentations for quota and Import Authorization.

Support related department in handling of Importation of Unregistered Controlled Substances.

JD 5 – Audits and Inspections

Assist the General Manager in ensuring internal and external audits are carried out in a smooth and efficient manner.

Monitor the effectiveness of CAPA after implementation.

JD 6 – Procedures, Processes and Practices

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).

JD 7 – Regulatory Implementations

Ensure all regulatory approved requirements are implemented according to the timeline (i.e., product variation, hologram labels and labeling of registered pharmaceuticals and medical devices).

JD 8 – Product and Customer Complaint

Monitor and document the process of complaints, ensure feedback is provided to the complainant according to the specified manner.

Raise SCAR to the supplier if related to product quality.

JD 9 - Product Recall

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 and principal.

Adhere to the responsibilities for Local Responsible Person for Pharmacovigilance based on the Guidelines issued by NPRA.

Oversee and manage all pharmacovigilance activities.

QUALIFICATIONS/REQUIREMENT:

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+ / MeDC@St 2.0+ Submissions.

Have experience in healthcare industries would be an advantage.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with office equipment.

Excellent communication and problem-solving skills.

Proficient in English and Bahasa Malaysia.

Based in Teraju Pharma Sdn Bhd (Bandar Bukit Raja Office).

Preference for candidates who are able to start immediately.