Regulatory Affair Submission Lead
Position: Full time
Open date: Jul 18, 2019
Functional area: Regulatory Affairs
Role Purpose 职位目的：
To lead the Regulatory Affairs Submission team on the development and planning of the regulatory submission strategies and to implement the submission strategies to deliver agreed registration milestones for support the business in a timely and effective manner.
To direct, manage and control the operational activities of subordinates and to develop the competency of regulatory submission staff through the implementation of appropriate training and process improvement programs.
Key Accountabilities/Responsibilities 主要工作职责：
1. Responsible for overall process of submission dossier preparation and submission for all life cycle activities, including new products (IND/CTA/NDA) and established products (renew and variation).
2. Develop a best-in-class submission registration team to meet the current and future business needs in China.
3. Provide leadership in the development of submission strategies for GSK projects, and effectively manage all submission projects in GSK portfolio.
4. Provide high standard of the submission documents with a first-time-right approach to minimize the CDE review timeline and to ensure the agreed registration timelines are delivered.
5. Responsible for module 1 documents preparation, such as certificate documents, INN, trade name, patent, etc. Responsible for dossier format, labelling and artwork execution.
6. Establish and maintain a good relationship with key regulatory authorities, effectively communicate to all key stakeholders to ensure all submission issues are well consulted/communicated with NMPA /CDE and clearly communicated with GRA and local teams.
7. Provide timely and high-quality regulatory submission support and input to internal key stakeholders such as medical, commercial and GMS site as needed.
8. Provide support and coach to regulatory submission colleagues in the team to solve the submission problems occurred during registration to achieve registration approvals in a timely and effective manner.
9. Provide strategic and technical regulatory submission input and support to Head of Regulatory Affairs for the capability development, improvement and management of the regulatory organization.
10. Oversight budget and implementation in accurately and timely manner for submission projects.
11. Responsible for system maintenance and archiving, ensure that regulatory information management system is updated, and registration documents are archived timely.
12. 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)
13. A minimum of bachelor degree in life science (pharmacy, chemistry, biology or related background) plus 8 years regulatory affairs working experience and over 3 years leadership role experience in MNC Company.
14. Proven ability to communicate (written/oral) in English
15. Ability to build, maintain and lead an efficient and well-motivated team
16. Good verbal and written communication skills
17. Ability to present clearly and effectively to a variety of audiences inside and outside
18. Good leadership and people-management skills
19. 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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