**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 cu...