(Senior) Regulatory Affairs Manager

Prepare local documents, submit and follow up registration applications, under supervision of the Head of Affiliate Regulatory Affairs, to ensure that marketing authorizations are obtained or maintained in line with the business plan.

Lead and be responsible for driving regulatory affairs activities for Taiwan Rare Disease portfolio.

Ensure to file new product registration and update the current registration file in timely manner.

Renew and revise the existing product license to ensure all are valid and compliance with regulation.

Maintain currency of labeling, pack leaflets in accordance with local regulations and corporate data sheet.

Ensure accurate translations of relevant documents.

Establish good relationship with Health Authority officers.

Establish good relationship with GRA regional/global regulatory staff ...