Senior RA manager/Associate RA Director
1. Preparing and submitting the documentation for new registrations and renewal of existing regulatory approvals for finished product imports. Current scope includes:
• Import :
• Current products IDL renewal and its variation
• New products registration
• Localization: Repackaging license and its renewal
2. Commercial supplying: to trace all commercial goods CoAs from NICPBP
3. Cooperate with GSKBS GMP certificate
4. Regulatory Affairs:
• Regulation search and distribute to relevant parties internally
• Involve in regulation influence activities
• Involve in related industry regulatory activities
• Establish, maintain and develop good relationships with the State Drug Administration (SDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
• Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.
• Ensure that GSK Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.
• Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
• Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
• Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SFDA and GSK requirements.
• Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
• As required co-ordinate activities with GSK Bio RA.
• Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).
• Possesses a Bachelor degree in medicine, Biological or medical
• Over 5 years regulatory affairs experience, and 2 years experience of assistant manager or manger
• Have vaccine regulatory experience is preferred
• Strong verbal and written communication skills.
• Expert knowledge of regulatory policies and registration processes in China.
• Excellent inter-personal skills.
• Extensive and close contacts with KOLs and experts.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Meet Some of GlaxoSmithKline's Employees
Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.
Back to top