Overall purpose of job
The Regulatory Affairs Specialist is responsible for all activities pertaining to product registration, regulatory submissions and national programs which JnJ initiates including registration amendments, drug reports, promotion activities, company registration/ renewals. He/she is also responsible for developing packaging artworks of registered products,ensuring compliance to the company SOP and ensuring that the company’s legal compliance is in line with relevant regulations. The Regulatory Affairs Specialist also provides regulatory advice to Company colleagues
Regulatory Approval (new registration, renewal registration, variation registration)
- Prepares, submits, coordinates and follows up on product registration as assigned.
- Meets submission due date of updated CCDS of products under responsibility.
- Ensure timely approval according to product registration plan.
- Handles correspondences with concerned parties, overseas and local, internally
- Supply the required information/documents for requirements of external or internal colleagues including Health Authorities (Ministry of Health) to conform to Company’s regulations and law.
- Handles any amendments to registered products under responsibility.
- Facilitate applications to get import quota by coordinating with supply chain department.
Company’s Legal Compliance
- Monitors legal compliance of company’s activities to conform to relevant
- Manages and arranges all regulatory drug reports under responsibility and ensure that they are maintained and/or timely submitted to the regulatory authorities in accordance with relevant regulations.
- Manages and ensures timely register/renewal of company with MOH.
- Monitors the arrival drugs imported in order to ensure that they comply with the regulatory authority approval.
Ensure the compliance of relevant regulation of Ministry of Health and other concerned authorities.
Coordinating with supply chain department to support for product’s availability on market.
Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
Provides professional comments, recommendations and requested information on legal documents to local and oversea colleagues.
Packaging Artwork Development
- Arrange translation of packaging insert and prepare artwork to comply with law and company’s regulation.
- Prepare additional text to product label as requirement from Vietnam DAV
- Coordinate with AW/plant’s colleagues in developing the artwork for packaging materials of registered products
Coordinate with Head Quarter and other partners when required.
Comply with general regulation of company and regulatory affairs department.
- Skills: Computer skills included be good at using Microsoft office software, AW design software.
- Internal systems: understand and work on the systems well.
- Language proficiency in English, Vietnamese