[Factory 1] RA Officer (Pharmacy/ Chemical/ Biotech)

Mô tả Công việc

1, Regulatory Compliance:

• Ensuring that company's products comply with the local regulation;
• Stay up-to-date with local, national, and international regulations and standards pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
• Checking monthly intellectual property gazette and providing advice/warning to senior management of the products;
• Support in training to internal teams on regulatory matters, ensuring a company-wide understanding of compliance requirements.

2, Product Registration:

• Preparing submissions of licence variations and renewals to strict deadlines pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
• Developing and writing clear arguments and explanations for product licences;
• Monitoring and setting timelines liaising with, and making presentations to regulatory authorities.

3, Cross-functional Collaboration

• Collecting, collating and evaluating scientific data that has been researched by colleagues;
• Advising scientists and manufacturers on regulatory requirements;
• Review and check for product labeling and packaging materials from Marketing dept. to ensure compliance with regulatory requirements;
• Collaborate with R&D, Manufacturing, Marketing, and other departments to align regulatory requirements with product development and commercialization goals;
• Collaborate with relevant departments to execute the company's strategic initiatives (ISO 14001, Cosmetic GMP, CE Marking Certificate, etc.)

4, Collection and management of post-market surveillance and pharmacovigilance information

• Receiving, recording, and monitoring the database of all reports related to drug safety (ADRs, medication errors, suspected adverse events (AE) related to medicines, etc.) from various sources (healthcare professionals, medical examination and treatment facilities, etc.);
• Preparing and submitting periodic safety update reports (PSURS) in accordance with regulations.

5, Follow other duties required from Manager.

Yêu Cầu Công Việc

• Bachelor's Degree OR Master Degree – Science & Technology Major (Pharmacy, Chemical Engineering/ Biotechnology or equivalent)
• Fresh graduate or at least 1 year experience in RA
• Good command of English (speaking, reading, writing)
• Proficient in MS Office
• Further information about career opportunities, please visit website: rohto.com.vn (Tuyển dụng -> Cơ hội nghề nghiệp)

• Any questions about this job, please contact us via Linkedin: Rohto Mentholatum VN