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
- 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 r egulations .
- Compile registration applications for assigned portfolio and ensure timely approval .
- Monitor progress of submissions & coordinate timely responses to all questions from the health a uthorities .
- 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
- 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
- Cross-functional collaboration and support
- Provide regulatory consultation & collaborate with local business stakeholders
- Provide feedback to the implementation of global initiatives when required
- 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: [Confidential Information]
Our Company
Why Boehringer Ingelheim
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more Visit https://www.boehringer-ingelheim.com
