Regulatory Affairs Director - Respiratory TA Lead
- Beijing, China
Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A
Posted Date: Mar 13 2020
Role Purpose 职位目的：
To lead the Specific Therapeutic Area Regulatory Affairs team on the development and planning of the regulatory strategies and to implement the strategies to deliver agreed product 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 staff through the implementation of appropriate training and process improvement programs.
Key Accountabilities/Responsibilities 主要工作职责：
- Develop a best-in-class registration team to meet the current and future Therapeutic Area business needs in China.
- Provide leadership in the development of registration strategies for Specific Therapeutic Area products.
- Effectively manage all registration projects in Specific Therapeutic Area portfolio. Effectively communicate to all key stakeholders to ensure all scientific and regulatory issues are well consulted/communicated with NMPA/CDE and clearly communicated with GRA and local teams;
- Establish and maintain a good relationship with key regulatory authority in daily work such as NMPA, CDE, NIFDC, etc via professional communication.
- 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.
- Provide support and coach to regulatory colleagues in the team to solve the problems occurred during drug registration to achieve drug registration approvals in a timely and effective manner.
- Provide strategic and technical regulatory input and support to Head of Regulatory Affairs for the capability development, improvement and management of the regulatory organization.
- Make sure to generate competitive PIs which comply with NMPA and GSK requirements.
- Ensure the maintenance for all registered Specific Therapeutic Area products.
- Oversight budget and implementation in accurately and timely manner for Specific Therapeutic Area
- Provide timely and high quality regulatory support and input to internal key stakeholders such as medical, commercial and GMS site as needed.
- Establish and maintaining inter/ intra departmental processes and channels of communication.
- A minimum of bachelor degree, preferable higher, (pharmacy, medical or related background) plus 10 years regulatory affairs working experience and over 5 years leadership role experience in MNC Company.
- Proven ability to communicate (written/oral) in English
- Ability to built, maintain and lead an efficient and well-motivated team
- Good verbal and written communication skills
- Ability to present clearly and effectively to a variety of audiences inside and outside
- Good leadership and people-management skills
- Ability to handle with emergency things and provide quick response
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
This is a job description to aide in the job posting, but does not include all job evaluation details.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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