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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: Provide regulatory strategy to innovative and established product: 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. Interaction with internal stakeholders: 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. Keep good communications with China Health Authorities on project& TA portfolio level: 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. Team/people development: 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) Master’s degree or PhD or equivalent in the field of Life Sciences / Pharmacy / professions aligned to medicine Relevant industry experience in Regulatory Affairs of which a considerable part has been in a senior role in multinational companies leading regulatory teams. Experience of working in specific TA group with a history of positive working relationships with the regulatory authorities. Experience of working in diverse multi-cultural teams. Experience of working effectively in a matrix across functions. 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: Patients have access to products with minimal possible interruption of supplies because of changing regulatory requirements and GSK continuous improvement of products; Supplied products are in compliance with the registered details so there is no risk for patient safety or reputational risk for GSK; Risk of mistakes in product information is managed properly to minimize impact of regulatory related mistakes on business, therefore ability to assess and communicate possible risks and to prepare the mitigation strategy is required; 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. 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. 致候选人的重要提示: GSK招聘团队只会使用 @gsk.com 后缀的邮箱与您联系。若您收到任何声称来自GSK邀请您面试或请您提供任何个人信息的邮件,我们建议您留意发件人的邮箱地址,并谨慎回复。若您不确定您所收到的邮件是否来自GSK,请您通过chk.recruitment@gsk.com联系我们。 We are 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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site
Beijing China

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Apply - Regulatory Affairs Therapeutic Area Lead (Classic Established... Beijing