Associate Director, CMC
Position: Full time
Open date: Jul 17, 2019
Functional area: Regulatory
Role Purpose 职位目的：
To lead and direct the regulatory staffs to provide strategic and technical regulatory support to line director for the purpose of commencing and maximizing GSK China Rx business by facilitating the submission and approval in a timely and cost-effective manner.
Key Accountabilities/Responsibilities 主要工作职责：
1. Significantly contribute to decision making on drug registration leading to minimal registration timeline. For instance, analysis and comparing the registration patterns to advice the best registration approach.
2. Build up a registration team with competitive position in Chinese pharmaceutical J-V Company.
3. Direct regulatory staffs to solve the problems occurred during drug registration in uncertainty Chinese pharmaceutical environment to achieve drug registration approvals in timely and cost effective manner.
4. Provide strategic and technical regulatory input and support to line director to contribute for decision making on drug registration to minimal registration timeline, review the new product timeline to monitor every milestone to be matched with reasonable timeline and controlled condition.
5. Make sure to generate competitive PIs which comply with SFDA and InRA requirements.
6. Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NICPBP, BDCI, etc.
7. Draw up and reviewing budget and drug registration timeline.
8. Collection information such as regulations, guidelines and competitive products etc.
9. Make sure InRA fully informed products registration status in China.
10. Provide the regulatory support to marketing and manufacturer and supervise them from regulatory point of view.
11. Establish and maintaining inter/ intra departmental processes and channels of communication.
Qualifications/Requirements: (Education / Experience / Competencies)
申请资格 / 职位要求：(教育背景 / 工作经验 / 知识与技能)
1. A minimum of bachelor degree (pharmacy, medical or related background) plus 3-5 years SOE's working experience, 3-5 years regulatory affairs working experience and over 2 years regulatory affairs manager experience in J-V Company.
A minimum of master degree (pharmacy, medical or related background) plus 5 years regulatory affairs working experience and over 2 years regulatory affairs manager experience in J-V Company.
2. Proven ability to communicate (written/oral) in English
3. Ability to built, maintain and lead an efficient and well-motivated team
4. Good verbal and written communication skills
5. Ability to present clearly and effectively to a variety of audiences inside and outside
6. Good leadership and man-management skills
7. Ability to handle with emergency things and provide quick response
You may apply for this position online by selecting the Apply now button.
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