Regulatory Affairs Therapeutic Area Lead - Beijing, 中国 - 1215 GlaxoSmithKline (China) Investment Co Ltd

描述

Role Purpose :

Lead responsible Therapeutic Area (TA) in Regulatory Affairs organization in China to contribute to growth and profitability of GSK LOC business, to develop local regulatory strategies for responsible portfolio and contribute to regulatory strategies as well as to ensure implementation of these strategies through regulatory submissions and approvals. Proactively anticipate and mitigate regulatory risks of responsible TA. Ensure compliance of responsible TA with China regulatory requirements.

Key Accountabilities/Responsibilities :

1. Develop Local regulatory strategies for responsible portfolio and contribute to global regulatory strategies in alignment with the Regulatory Affairs objectives and the in-country functions (Development Commercial, Medical etc.).

2. Implement timely local regulatory strategies in alignment with GSK processes and KPIs.

3. Maintain high standards of regulatory excellence e.g., right first-time submission, accurate labelling.

4. Facilitate the strategic deployment of regulatory projects through prioritization, allocation of resources and enabling communication across functions within LOC, at the regional and central level.

5. Implement regulatory risk assessment for project and able to provide input on regulatory precedence and product characteristics.

6. Ensure the regulatory compliance of responsible TA.

7. Communicate effectively with the Global Regulatory Affairs and key stakeholders across functions to ensure all scientific and regulatory points are appropriately analyzed, communicated and aligned for further communication to the regulatory authorities.

8. Attend the global RMT mtgs represents China RA, to build and implement China regulatory strategy

9. Support the TA/CRMT leads, represent China RA team in the TMT to provide strategic, scientific and high-quality Regulatory input. Actively involved in decision making on key development questions in consideration of the responsible portfolio.

10. Communicate effectively with the regulatory authorities to ensure GSK data and position are clearly presented and professionally discussed.

11. Lead and support the TA/CRMTs lead in the communication with the CDE for responsible projects.

12. Ensure appropriate advocacy strategies are in place to shape evolving legislation/regulatory requirements in partnership with relevant experts.

13. Develop a best-in–class regulatory TA teams to meet the current and future responsible business needs in China.

14. Ensure personal and professional development of the staff through a coordinated, well managed, strategically aligned program that applies development objective setting and talent review processes ensuring that the best people with the right skills are in place to support regulatory activities for responsible portfolio in the short term and a succession stream is developed for a longer term.

15. Being part of LOC Regulatory LT, support Head of Regulatory Affairs within the area of expertise as well as by contributing as a leader to establishing objectives, priorities, staff development, governance and oversight, budgeting control.

Qualifications/Requirements: (Education / Experience / Competencies)

Competencies

1. Advanced knowledge of the policies, key personnel and regulatory climate in the market.

2. Advanced knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry.

3. Proven track record of effective collaboration with the regulatory authorities and a history of success in gaining product approvals and defending established products.

4. Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints.

5. Insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges with teams.

6. Strong management and project leadership skills, ability to provide operational oversight and support project teams in strategic decisions and guide them through diverse and conflicting regulatory requirement.

7. High degree of comfort and positive engagement working as a member of a multifunctional team, both in a leadership role and as a senior contributing member.

8. Ability to influence and manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options.

9. Ability to anticipate possible changes in regulatory requirements proactively, to monitor their implementation, to present management with recommendations that reflect full consideration of available options. Since many regulations / expectations in the market are not written or are written in a very general manner, a deep knowledge of common practice and ability to get information from different external sources and then to analyze it is key. Due to the nature of regulatory procedures, such decisions should be taken very quickly and in advance, hence the requirement have significant experience and relevant skill.

10. Works in one of the most critical areas in terms of compliance to ensure:

11. Works in one of the fast-changing areas where changes are caused by external factors (regulatory requirements and practices), business needs and central procedures of compliance and product improvements, therefore ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment is required.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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