EXT - Regulatory Affairs Executive
This is an agency‑hired role supporting the Regulatory MSI Department for Boehringer Ingelheim Malaysia. The successful candidate will be employed by the agency and assigned to Boehringer Ingelheim Malaysia. This role is not a direct employment with Boehringer Ingelheim.
The Position
Are you ready to take on a role where your regulatory expertise drives healthcare innovation forward?
This role is responsible for achieving timely and successful product registrations in accordance with corporate and local strategies, collecting and sharing updates on new regulations and guidelines with the local RA team, and ensuring compliance with company regulatory policies, regulations, and procedures.
Task & Responsibilities
Regulatory Planning and Submission
- Support the regulatory tasks & projects, including attaining, maintaining product and operation licenses for assigned portfolio.
- Support the compilation of registration applications for assigned portfolio and ensure timely approval.
- Monitor submission progress of submissions and coordinate timely responses to health authority queries.
- Comply with corporate policies, regulations & procedures, timely implementation of Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures.
Regulatory Intelligence and Interaction
- Collect and share new or updated local regulations from various sources with the local RA team.
- Communicate with Regulatory Authorities and local industry groups on regulatory issues.
Cross-functional collaboration and Support
- Provide administrative support to local RA team for regulatory consultation and collaboration with local business stakeholders.
- Support and contribute to local or global initiative and project implementation.
Quality and Compliance
- Perform timely administrative entries in regulatory databases across all products in the assigned territories to reflect current registration status and requirements.
- Support the local RA team for audits and inspection readiness.
- Archive local regulatory submission documents.
Requirements
- Degree in Pharmacy or Life Sciences or equivalent professional qualifications.
- 1 to 3 years of experience working in the pharmaceutical, generic, medical device or healthcare industry.
- Good knowledge of national drug regulations and procedures.
- Good communication skills for internal & external interactions.
- Good computer literacy skills, Microsoft Office proficiency, comfortable working with databases.
- Analytical mindset and meticulous attention to detail.
About the Assignment Company
Boehringer Ingelheim Malaysia is the host company for this assignment. In this role, you will support Boehringer Ingelheim’s Regulatory MSI Department activities while being employed by the agency.
Why this assignment?
This role offers the opportunity to work closely with Boehringer Ingelheim teams on meaningful operational initiatives in a fast-paced environment. Please note that this is an agency-hired assignment, and all employment terms and conditions will be managed the agency.