Job Description

The Position

• 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.

Duties & Responsibilities1. Regulatory Planning and Submission

• Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses for assigned portfolio on behalf of BI 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

2. Regulatory Intelligence and Interaction

• 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

3. Cross-functional collaboration and support

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

4. Quality and Compliance

• 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

Requirements

• Degree in Pharmacy preferred
• 1~3 years of experience working in the pharmaceutical, medical device or healthcare industry is preferred
• Good knowledge of National Drug Regulations and Procedures
• English proficiency
• Good communication skills for internal & external interactions
• Good computer literacy skills, comfortable working with databases

Note to Recruitment Agencies:Boehringer Ingelheim (BI) does not accept candidate submissions from recruitment agencies that BI does not have existing contracts with. BI will not be responsible for payment of recruitment fees for the hiring of candidates whose resumes were submitted to BI employees or BI offices without BI\'s prior permission.

Boehringer Ingelheim