**The Position** **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. **Duties & Responsibilities** **1. Regulatory Planning and Submission** + Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses for assigned portfolio on behalf of BoehringerIngelheim 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** **Minimum Education** **/** **Degree Requirements** **:** Bachelor’s degree in Pharmacy preferred **Skills required:** + 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 **Experience:** Minimum 3 years of experience working in the pharmaceutical, medical device or healthcare industry with strong performance record in the previous position. **READY TO CONTACT US?** Please contact our Recruiting Team: Ms. Phuong Vo: phuong.vo@boehringer-ingelheim.com All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.