Regulatory Affairs Specialist, Human Pharma

Hanoi - Vietnam

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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: Bachelors 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:

Required Experience:

The PositionRegulatory Affairs Specialist Human PharmaTo 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 polici...