Participate in all activities related to regulatory affairs to support registration in Taiwan markets.
Responsible to compile and submission of dossier for new products according to local requirements for registration in Taiwan.
Prepare appropriate documentation for renewing licenses in Taiwan markets.
Prepare amendment and notification submissions in compliance with application regulations (Change Control).
Prepare in the development and implementation of regulatory strategies and update strategies based upon regulatory changes.
Liaise with external parties and cross-function teams to obtain information and documents for regulatory submission.
To maintain current knowledge base of existing and emerging regulations standards, or guidance documents in order to update company on new regulations / new procedures.
Keeping up-to-date with changes in regulatory legislation.
Education and Experience
Bachelor’s Degree in Science, Pharmacy, Chemistry or relevant disciplines
At least 8+ years of relevant experiences in Regulatory Affairs area of Pharmaceutical or Medical Device industry
Prior experience with the Medical Device Regulations and Common Submission Dossiers Template (CSDT) is added advantage
Quality orientation and high attention to detail
Excellent interpersonal and communication skills
Self-motivated and able to work independently with minimal supervision
Ability to adapt in a fast-paced setting with evolving goals and objectives
Fluent in written and spoken English
Minimal travel as required
Contact Details : randy.chen springasia.com