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 i