Are you a seasoned Regulatory Affairs professional looking to advance your career with a globally renowned pharmaceutical company? Abbott Pharmaceutical is seeking a Regulatory Affairs Executive to join their team in Binh Duong, Vietnam. This is an exciting opportunity to contribute to the registration and compliance of life-changing pharmaceutical products while working in a dynamic and supportive environment.
About Abbott Pharmaceutical
Abbott is a leading global healthcare company dedicated to helping people live healthier lives. With a portfolio spanning pharmaceuticals, medical devices, diagnostics, and nutrition products, Abbott is committed to delivering innovative solutions that improve health outcomes worldwide.
Key Responsibilities
As a Regulatory Affairs Executive, you will play a critical role in ensuring compliance with local regulations and maintaining the company’s product registrations. Your responsibilities will include:
1. Registration of New and Existing Products
- Review and compile registration dossiers for new, renewal, and variation registrations.
- Maintain Marketing Authorizations (MAs) in compliance with local regulations.
- Ensure the availability of updated registration documents and samples.
- Follow up with regulatory authorities weekly to expedite approvals.
- Initiate, monitor, and update regulatory reports in a timely manner.
2. Registration of Promotion Materials
- Compile and register promotional materials to ensure compliance with local laws.
- Ensure all promotional content aligns with regulatory standards.
3. Regulatory Intelligence
- Stay updated on new regulations and changes that may impact the business.
- Inform the Head of Department and relevant stakeholders about regulatory updates.
- Implement new regulations effectively to ensure compliance.
Requirements
To excel in this role, you should possess the following qualifications:
Work Experience
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of local and international regulatory standards.
Competencies
- Strong communication and negotiation skills to liaise with regulatory authorities.
- Excellent problem-solving and analytical thinking abilities.
- A team player with the ability to collaborate across departments.
Language Skills
- Fluency in English (both written and spoken) is essential.
Why Join Abbott Pharmaceutical?
- Global Impact: Contribute to improving health outcomes on a global scale.
- Career Growth: Access to professional development opportunities within a leading healthcare company.
- Innovative Environment: Work with cutting-edge pharmaceutical products and technologies.
- Supportive Culture: Be part of a team that values collaboration, diversity, and inclusion.
