Job Description

Salary Market Aligned

Location Kuala Lumpur FULL_TIME

Consultant Sashi Lim

Job Ref J40M15-0F5023D8

Date posted 27 July 2023 kuala-lumpur healthcare-and-life-sciences/regulatory-affairs-and-quality-assurance 2023-07-27 2023-09-25 pharmaceuticals kuala lumpur MY Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true

An exciting RA Manager job has become available at a pharmaceutical company in Malaysia.

About the RA Manager Role:
In this role, you will be responsible for implementing and adhering to regulatory submission plan for new product registration and product license maintenance, and 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 your custodian.

Key Responsibilities:

• Collect, collate and evaluate all technical documents for adequacy and accuracy before compilation and submission of dossiers to regulatory authorities. This is 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
• 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
• 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
• 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
• 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
• 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
• Initiate and coordinate the change control involving registered particulars. Ensure smooth changeover of newly registered particulars within committed timeline to the regulatory authorities
• Prepare package inserts and patient information leaflets required for product registration submission. Review product labelling, advertising and promotional materials as to ensure company is complied with the advertising regulatory requirements. Be attentive to product enquiries from marketing teams and end users
• 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
• Coordinate the submission of finished products and reference/working standards as required by the regulatory authorities under post market surveillance activities
• Plan and organise regulatory documentation for active pharmaceutical ingredients used in finished products
• Prepare regulatory submission in line with regulatory requirements in custodian countries
• Evaluate changes in the registered active pharmaceutical ingredients for regulatory impact with guidance. Accurately describe these changes for ease the review of regulatory authorities
• 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
• 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
• Be involved in quality system internal audit and/or client audit for regulatory compliance assessment as and when deemed necessary
• Develop standard operation procedures for activities and registration processes in term of regulatory compliance
• Gain knowledge of applicable regulatory requirements in custodian countries, and provide input to management to ensure products are manufactured and marketed in compliance with appropriate regulations
• Participate in product development, quality assurance, manufacturing and marketing team projects as to ensure all practices and outcomes are complied with regulatory requirements

To succeed in this RA Manager role, you will need to have the ability to work independently with minimal supervision.

Key Requirements:

• Bachelor\'s degree in science-related field or pharmacy with two or more years of proven experience in regulatory affairs within a pharmaceutical/ healthcare company or regulatory agency
• Preferably a background in degree in pharmacy and a registered pharmacist in Malaysia

This company needs someone who is very hands-on and driven to expand the company business. It is a very team-based environment for the work culture within the company. The firm is also very focused on growing employees internally.

If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting RA Manager role.

Robert Walters