Regulatory Affairs Specialist, Human Pharma

• To achieve timely & successful product registrations in accordance with corporate & local strategies.
• To collect any information on new Regulations and Guidelines, and to share it in local RA team.
• To ensure compliance with Company regulatory policies, regulations & procedures.

• Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses for assigned portfolio on behalf of Boehringer Ingelheim as required by local regulations.
• Compile registration applications for assigned portfolio and ensure timely approval.
• Monitor progress of submissions & coordinate timely responses to all questions from the health authorities.
• Be Compliant with Corporate policies, regulations & procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures

• Responsible to collect new or updated local regulations via various potential sources and keep the local RA team and ROPU informed
• Communicate with Regulatory Authorities and local industry groups on regulatory issues

• Provide regulatory consultation & collaborate with local business stakeholders
• Provide feedback to the implementation of global initiatives when required

• Timely submission of CCDS, CRC, Renewals, PSUR and other local variations in compliance with internal KPIs
• Ensures that regulatory database is up to date to reflect the current registration status or regulatory requirements
• Support local inspection readiness
• Archiving of local regulatory submission documents

• Good knowledge of National Drug Regulations and Procedures
• Good communication skills for internal & external interactions
• Proactive and assertive attitude
• English proficiency
• Good computer literacy skills, comfortable working with databases

Boehringer Ingelheim