SENIOR REGULATORY AFFAIRS EXECUTIVE

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

Responsible for providing regulatory expertise to Regulatory Affairs Unit, Activ Pharma Sdn Bhd, and for ensuring the company’s Pharmaceutical and Medical Device operations are in compliance with the requirements of the local Regulatory Authorities.

Leading a subunit providing couch coaching mentoring to other Regulatory Affairs personnel.

General Responsibilities

Regulatory Affairs

Supporting the Regulatory Affairs team in submitting regulatory applications (submission, renewal, and variation) and obtaining timely approvals from the Regulatory Authorities.

Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships.

Responsible for compiling dossiers in a timely manner for new product registration, product amendment, and product license renewal.

Monitor product registration status and ensure validity of registrations.

Maintain close liaison with regulatory authorities and overseas partners for all matters pertaining to registration and regulatory.

Support the teams by providing advice on regulatory requirements and strategy.

Other regulatory tasks as assigned by superior.

Pharmacovigilance (PV)

Responsible for instituting and maintaining the key aspects of Pharmacovigilance/Vigilance Management which consist of, but are not limited to, the following:

• Maintenance of local Pharmacovigilance System (PSMF)
• Preparation and maintenance of the standard operating procedures (SOPs) and other controlled quality documents
• Performing trend analyses, compliance checks, and predictive modelling for compliance operations
• Participating in Inspection/Audit, development of corrective action plans, and Corrective and Preventative Action (CAPA) implementation

Functional Skills And Knowledge

Demonstrate strong understanding and expertise in the Pharmaceutical Industry.

Relevant experience in Regulatory Affairs, especially in the Pharmaceutical & Medical industry.

Proficiencies in Microsoft Excel & Quest3.

Ability to work in a team with attention to detail and able to work under pressure.

Demonstrate fluency in English, both written and spoken.

Education

Bachelor's Degree in Pharmacy & Science with a minimum 2-5 years of relevant work experience in the Pharmaceutical industry.