Regulatory Affairs Specialist — Product Registrations

Boehringer Ingelheim GmbH; Malaysia; On-site; MYR 42,000 - 66,000; Full time

Job summary

Boehringer Ingelheim Malaysia is seeking a Regulatory MSI Associate to join the agency‑hired team. You will support product registrations and regulatory submissions under local strategies.

You will collect updates on new regulations, liaise with authorities, and ensure compliance with CCDS, CRC, and local change controls. This assignment is managed by the agency, with employment terms set by the agency while you contribute to Boehringer Ingelheim Malaysia's regulatory operations.

Qualifications

• Degree in Pharmacy or Life Sciences or equivalent qualifications.
• 1–3 years experience in pharmaceutical, generic, medical device or healthcare industry.
• Good knowledge of national drug regulations and procedures.
• Good communication skills for internal and external interactions.
• Good computer literacy, Microsoft Office, and database skills.
• Analytical mindset with meticulous attention to detail.

Responsibilities

• Regulatory Planning and Submission: Support regulatory tasks & projects, including attaining, maintaining product and operation licenses for assigned portfolio.
• Monitor submission progress and coordinate timely responses to health authority queries.
• Collect and share new or updated local regulations with the local RA team.
• Provide administrative support to local RA team for regulatory consultation and collaboration with local business stakeholders.
• Perform timely administrative entries in regulatory databases across all products in the assigned territories to reflect current registration status and requirements.

Skills

Communication skills

Analytical mindset

Attention to detail

Microsoft Office proficiency

Database literacy

Education

Degree in Pharmacy or Life Sciences or equivalent professional qualifications

Tools

Microsoft Office

Databases

Job description

Boehringer Ingelheim Malaysia is seeking a Regulatory MSI Associate to join the agency‑hired team. You will support product registrations and regulatory submissions under local strategies.

You will collect updates on new regulations, liaise with authorities, and ensure compliance with CCDS, CRC, and local change controls. This assignment is managed by the agency, with employment terms set by the agency while you contribute to Boehringer Ingelheim Malaysia's regulatory operations.