上海招聘

职位描述：
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 approvals by the FDA EDQM, and other EU health authority. 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, to work closely with our European team and monitor projects for the EU market.


Associate Director - Regulatory Affairs


Major responsibilities:

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

• Conduct audit as per EU GMP and regulatory assessment as per 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 EU GMP compliance.
  
• Coordinate and participate in supplier audit by customers and pre-approval inspection by regulatory authorities.
  
• Provide DMF/CTD document support.
  
• Provide consulting service on general EU GMP topics.

Basic requirements:

• At least university degree in chemistry or pharmacy or a comparable qualification
  
• Minimum 5 years direct experience in pharmaceutical QA/regulatory
  
• Familiar with EU GMP requirements
  
• Minimum 3 years audit experience, mainly as lead auditor
  
• GMP professional English (oral and written)
  
• Self-starter, team player with good communication skill
• Ability to travel extensively

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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.