上海招聘

Regulatory Affair Assistant

Major responsibilities:

· Provide guidance and support to ensure Flavine suppliers are in continued state of GMP compliance.

· Conduct regulatory assessment and audit per USFDA and EDQM requirements.

· Evaluate potential suppliers for their quality systems and compliance with appropriate regulatory requirements.

· Identify deficiencies and create overall plan to assist suppliers achieve GMP compliance.

· Coordinate and participate in supplier audit by customers and pre-approval inspection by regulatory authorities.

· Provide DMF/CTD document support with compilation and review.

· Provide consulting service on general GMP topics .



Basic requirements:



· Advanced degree in pharmaceutical or scientific areas

· Minimum 3 years direct experience in pharmaceutical QA/regulatory

· Proficient in English, both written and oral

· Self-starter, team player with good communication skill

· Ability to travel extensively

Flavine is an international company with offices in USA, Germany, India, and China and has been linking advanced Active Pharmaceutical Ingredient (API) manufacturers with markets and pharmaceutical companies since 1975. We have added value to the businesses of both suppliers and customers by locating and developing quality manufacturers and opening up new markets. This includes assisting with regulatory compliance, ensuring swift development of new products and on-time delivery. We represent more than 20 manufacturers holding DMFs and CEPs and offer hundreds of APIs and intermediates. Our development and regulatory personnel coordinate and manage product development and regulatory documentation projects to ensure FDA and other health authority approvals. Shanghai Office was established in 2004 and has been instrumental in serving the need of API manufacturers in China with GMP/Regulatory support and international marketing/sales. We are looking for highly motivated, intelligent, and honest individual to join our Shanghai team.