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 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

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 informedCommunicate with Regulatory Authorities and local industry groups on regulatory issues

3. Cross-functional collaboration and support

Provide regulatory consultation & collaborate with  local business stakeholdersProvide 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 KPIsEnsures that regulatory database is up to date to  reflect the current registration status or regulatory requirementsSupport local inspection readinessArchiving 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 ProceduresGood communication skills for internal & external interactionsProactive and assertive attitudeEnglish proficiencyGood 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