行业：Healthcare
职位：Pharmacy
部门：
人数：若干
性质：Full Time
性别：Male
婚姻：No marital status restrictions
学历： Bachelor's Degree
经验：不限
年龄：18岁以上
待遇：面议
REGULATORY PHARMACIST:
Requirements:
Must be a licensed/registered Pharmacist with a good scholastic record.Preferably with work experience in the Regulatory field, but fresh graduates and no experience in Regulatory can still be accommodated.Must have excellent analytical and critical thinking skills and has the ability to handle and process lots of information. Willing to be trained and is a fast learner, goal-oriented and committed to pursuing a long-term career within the company.Must have good written and spoken communication skills and the ability to multitask as well as work independently and under pressure.Meticulous and keen on details.Proficient in the use of digital tools/systems.Responsibilities:
Responsible for the preparation, evaluation, communication with suppliers and ensuring the correctness and consistency of necessary documents in accordance with the requisites of the local pharmaceutical regulatory per FDA guidelines for filing/submission of all FDA-related applications such as but not limited to Initial applications, Biologicals Drug Applications, Foreign GMP Clearance Applications, Variations, Notifications and Renewal Applications to be able to secure approval.Responsible for ensuring that all product registrations, licenses and Certificate of GMP Compliances are valid and submitted to FDA for renewal prior to their expiration date.Performs quality assurance on all artworks and labels in compliance with FDA local regulations and corporate policies.Performs regulatory-assigned activities and roles in support of business objectives.