SENIOR REGULATORY AFFAIR

WITPRISE SDN BHD; Selangor; Remote; MYR 100,000 - 150,000; Full time

Job summary

A leading company in Malaysia is seeking a Senior Regulatory Affairs Specialist to oversee submissions and manage regulatory activities. The ideal candidate will have over 4 years of experience and a relevant degree, with responsibilities including dossier preparation and collaboration with internal stakeholders. This role allows for remote work but requires occasional travel.

Qualifications

• More than 4 years of experience in Regulatory Affairs.
• Experience in preparing technical dossiers according to ASEAN requirements.

Responsibilities

• Oversee and train Regulatory Affairs Assistants.
• Manage regulatory submissions and correspondence with health authorities.
• Support local regulatory activities including product registration.

Skills

Regulatory Affairs

Collaboration

Technical Dossier Preparation

Education

Degree in Pharmacy

Bachelor in Science

Bachelor in Chemistry

Bachelor in Biotechnology

Job description

Work remotely overseeing and training Regulatory Affair Assistants on the submission of QUEST 3+ to NPRA and MDA Medc@st.

Lead and manage other Regulatory Affairs personnel and handle additional tasks as required from time to time.

Support local regulatory activities, including new and generic product registration, variations, and renewals.

Prepare and review dossiers prior to product registration, including compiling technical dossiers according to ASEAN Common Technical Dossier (ACTD) and Common Submission Dossier Template (CSDT) requirements.

Coordinate regulatory submissions and correspondence with local health authorities NPRA and MDA.

Collaborate with internal stakeholders on regulatory post-market surveillance activities and Good Distribution Practice (GDP) to ensure uninterrupted product supply and successful launch of new products.

Ensure timely response to relevant regulatory directives/circulars and execute tasks within deadlines set by authorities.

Proactively complete tasks assigned by Business Development Team or Director as needed.

Preferably with more than 4 years of experience in Regulatory Affairs, holding a Degree/Bachelor in Pharmacy, Science, Chemistry, Biotechnology, or related fields.

Work remotely but possess own vehicle and be willing to travel outstation when required.

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Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Regulatory Affairs professional?

Positions listed include:

• Senior Regulatory Affairs Specialist, APAC at ZOLL Medical Singapore Pte Ltd
• Regulatory Affairs Executive/Senior Executive at ELITE BEAUTY ASIA (MALAYSIA) SDN. BHD
• Regulatory & Administrative Executive at AURICLE ASIA SDN. BHD.

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