Regulatory Affairs Executive

Intrinseque Health; Malacca City; On-site; MYR 30,000 - 45,000; Full time

Job summary

A healthcare consultancy is seeking a talented Junior Executive Regulatory Affair to join their dynamic team in Malacca. This full-time position involves supporting regulatory processes in the pharmaceuticals and medical devices industry. Responsibilities include preparing regulatory documents, ensuring compliance, and monitoring regulatory changes. An ideal candidate will have a relevant bachelor's degree and familiarity with the regulatory landscape. Strong organizational and communication skills are essential for success in this role.

Qualifications

• Bachelor's degree in a relevant field.
• Familiarity with regulatory affairs processes.
• Strong attention to detail and organizational skills.

Responsibilities

• Assist in the preparation and submission of regulatory documents.
• Collaborate with teams to ensure compliance with laws.
• Monitor changes in regulatory requirements.

Skills

Attention to detail

Organizational skills

Communication skills

Interpersonal skills

Proficiency in Microsoft Excel

Proficiency in Microsoft PowerPoint

Education

Bachelor's degree in Pharmaceutical Sciences, Biomedical Sciences

Job description

About the role

We are seeking a talented Junior Executive Regulatory Affair to join our dynamic team at Intrinseque Health. This is a full-time position based in Melaka Tengah, Melaka. In this role, you will be responsible for providing support and assistance in navigating the complex regulatory landscape within the pharmaceuticals and medical devices industry.

What you’ll be doing

• Assist in the preparation and submission of regulatory documents for new product registrations, variations, and renewals
• Collaborate with cross-functional teams to ensure compliance with relevant laws, regulations, and industry standards
• Monitor and stay up-to-date with changes in regulatory requirements and guidelines
• Provide support in the implementation of quality management systems and procedures
• Participate in the review and analysis of post-marketing surveillance data and adverse event reports
• Contribute to the development and maintenance of regulatory databases and filing systems
• Assist in the coordination of regulatory inspections and audits

What we’re looking for

• Bachelor’s degree in a relevant field, such as Pharmaceutical Sciences, Biomedical Sciences, or a related discipline
• Familiarity with regulatory affairs processes and procedures in the pharmaceuticals and medical devices industry
• Strong attention to detail and excellent organizational skills
• Good communication and interpersonal skills, with the ability to work effectively in a team
• Proficiency in Microsoft Office applications, particularly Excel and PowerPoint
• Willingness to learn and adapt to changing regulatory requirements.