Regulatory Affairs Executive

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to ensure compliance with regulatory requirements for product registration and maintenance. This role involves liaising with regulatory authorities, managing submission timelines, and preparing necessary documentation. The ideal candidate will have a solid background in regulatory affairs, excellent attention to detail, and strong communication skills in English and Bahasa Malaysia. Join a dynamic team where your expertise will contribute to the successful launch and maintenance of pharmaceutical products in compliance with local regulations.

Qualifications

• 2+ years of experience in regulatory affairs within pharmaceutical or healthcare sectors.
• Direct interaction with regulatory authorities is essential.

Responsibilities

• Implement and adhere to regulatory submission plans for product registration.
• Coordinate with regulatory authorities for queries and submissions.

Skills

Regulatory Affairs

Attention to Detail

Interpersonal Skills

Written Communication

Verbal Communication

Education

Bachelor's Degree in Science

Bachelor's Degree in Pharmacy

Job description

Job Outline:

Responsible in implementing and adherence to regulatory submission plan for new product registration and product license maintenance. Act as a liaison with regulatory authorities and business partners (contract manufacturing, in-licensing and out-licensing partners) pertaining to product registration and clinical study activities in countries under her/his custodian.

Duties and Responsibilities:

1. To collect, collate and evaluate all technical documents for adequacy and accuracy before compilation and submission of dossiers to regulatory authorities. This inclusive but not limited to CTD (Common Technical Dossier) for pharmaceutical products, CSDT (Common Submission Dossier Template) for medical devices and PIF (Product Information File) for cosmetics.
2. Adhere to product submission milestone and prepare dossiers and/or regulatory documents required by custodian countries and business partners in a timely manner. Ensure timely registration of new products and regulatory compliance of marketed products.
3. To maintain product registration license by monitoring product renewal due date, and filing variation to drug authorities on any change(s) in product registered particulars by the company and/or business partners.
4. To apply licenses and permits which form parts of administrative requirements for product registration filing. Obtain endorsement for licenses and permits from legal firms and relevant authorities as required by regulatory authorities. Engage service providers for translation service if deemed necessary by the regulatory authorities.
5. To act as contact with the regulatory authority officials and business partners for queries pertaining to registering and maintaining products license. Always respond and attend to queries in a timely manner.
6. To manage and plan the variation submission accordingly whenever there is a change in product registered particulars. Ensure variation application is submitted based on the planned timeline and expedite the regulatory approval.
7. To initiate and coordinate the change control involving registered particulars. Ensure smooth changeover of newly registered particulars within committed timeline to the regulatory authorities.
8. To prepare package inserts and patient information leaflets required for product registration submission. Reviewing product labeling, advertising and promotional materials as to ensure company is complied with the advertising regulatory requirements. Attentive to product enquiry from marketing teams and end users.
9. To prepare documents required for tender application and ensure timely submission to the tender authorities within stipulated timeline. Ensure commitments made to the tender authorities are executed accordingly.
10. To coordinate the submission of finished products and reference/working standards as required by the regulatory authorities under post market surveillance activities.
11. To plan and organize regulatory documentation for active pharmaceutical ingredients used in finished products. Prepares regulatory submission in line with regulatory requirements in custodian countries.
12. To evaluate changes in the registered active pharmaceutical ingredients for regulatory impact with guidance. Accurately describe these changes for ease the review of regulatory authorities.
13. To coordinate with concerned departments, such as Quality Assurance/Quality Control/Manufacturing to ensure all regulatory requests pertaining to finished product specification, analytical testing, manufacturing process, in-process control and validation are managed accordingly within the stipulated timeline to the regulatory authorities and business partners.
14. To represent sponsor (company/business partners) in performing onsite clinical study monitoring. Ensure timely submission of regulatory application to the local authorities and to obtain necessary regulatory approval before initiating clinical study.
15. To be involved in quality system internal audit and/or client audit for regulatory compliance assessment as and when deemed necessary.
16. To develop standard operation procedures for activities and registration processes in term of regulatory compliance.
17. Gain knowledge of applicable regulatory requirements in custodian countries, and provide input to management as to assure products are manufactured and marketed in compliance with appropriate regulations.
18. Participate in product development, quality assurance, manufacturing and marketing team projects as to ensure all practices and outcomes are complied with regulatory requirements.

Minimum Requirements:

1. Bachelor’s degree in Science related field or Pharmacy with minimal 2 years proven experience in regulatory affairs within a pharmaceutical/ healthcare company or regulatory agency.
2. Relevant experience in direct interaction with regulatory authorities.
3. Possess high levels of accuracy and attention to details. Good interpersonal skills.
4. Good in written and spoken English and Bahasa Malaysia is essential; Chinese as an additional language would be advantage.