DƯỢC PHẨM HELIOS

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: [email protected]

Our Company

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Why Boehringer Ingelheim?

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

Want to learn more? Visit https://www.boehringer-ingelheim.com