Senior Regulatory Affairs Leader (Pharma & PV)

Jobstreet Malaysia; Selangor; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Regulatory Affairs professional to provide regulatory expertise and ensure compliance with local regulations. Responsibilities include supporting the regulatory team, compiling product registration dossiers, and liaising with regulatory authorities. The ideal candidate should have a Bachelor's Degree in Pharmacy & Science and 2-5 years of experience in the Pharmaceutical industry. Proficiency in Microsoft Excel and fluency in English are essential.

Qualifications

• Minimum 2-5 years of relevant work experience in the Pharmaceutical industry.
• Strong understanding of the Pharmaceutical industry required.
• Relevant experience in Regulatory Affairs, especially in the Pharmaceutical & Medical industry.

Responsibilities

• Provide regulatory expertise to ensure compliance with local authorities.
• Support the Regulatory Affairs team in submitting applications.
• Compile dossiers for new product registration and renewals.
• Monitor product registration status and validity.
• Advise on regulatory requirements and strategy.

Skills

Regulatory Affairs expertise

Pharmacovigilance knowledge

Attention to detail

Teamwork

Fluent in English

Education

Bachelor's Degree in Pharmacy & Science

Tools

Microsoft Excel

Quest3

Job description

A leading pharmaceutical company in Malaysia is seeking a Regulatory Affairs professional to provide regulatory expertise and ensure compliance with local regulations. Responsibilities include supporting the regulatory team, compiling product registration dossiers, and liaising with regulatory authorities. The ideal candidate should have a Bachelor's Degree in Pharmacy & Science and 2-5 years of experience in the Pharmaceutical industry. Proficiency in Microsoft Excel and fluency in English are essential.