Head of Regulatory Affairs, China
5 months ago
Job Purpose:
Head of Regulatory Affairs will provide leadership and strategic direction for the GSK China Regulatory Affairs team. The role will ensure the registration of new products and line extensions and manage the life cycle of the products in line with commercial and global regulatory objectives. The role will maintain strategic stakeholder relationships with key contacts internally and externally, including the regulatory authorities such as CDE and NMPA, and trade associations like RDPAC. The role will also ensure that the team operates in compliance with government laws and regulations.
Key Responsibilities:
Lead Regulatory Affairs team. Align regulatory plans and resources with local, regional, and global objectives. Develop professional relationships and effective communications with internal and external stakeholders. Ensure that all registrations and regulatory processes are in compliance with government laws and regulations and corporate standards. Ensure governance and oversight to ensure on-time fulfilment of regulatory obligations and expectations with the appropriate quality. Set objectives, manage team’s performance and hold them accountable for delivery. Train, mentor, and supervise members of Regulatory Affairs team. Enhance the team’s culture in alignment with the GSK culture. Enhance Policy, Advocacy, and Intelligence activities and network.Minimum Level of Education Required:
Bachelor's degree or Advanced degree in Life Sciences.Minimum Level of Job-Related Experience Required:
15 years of experience working in the pharmaceutical MNCs with direct extensive experience in Regulatory Affairs and management of 2nd line leaders. Demonstrated experience in taking products through early and late development, through to successful registrations and post-marketing licence maintenance. Experience across diverse therapeutic areas including Pharma, Vaccines, and Biopharma. Strong knowledge of the China regulatory framework and requirements; knowledge of international regulatory processes particularly in the EU and USA systems. Experience in advocating to shape regulatory environment.Key Capabilities:
Leadership of big teams with empowerment and holding the team accountable. Strong matrix leadership, proven ability to effectively and collaboratively work with cross-functional teams. Excellent written and verbal communication skills. Proven ability to influence at the global level. Good commercial awareness, good understanding of how the business works, and how regulatory matters can impact business objectives. Excellent eye for detail.Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
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：
-
Strategic Regulatory Affairs Director
1 month ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeJob DescriptionHead of Regulatory Affairs for GSK in China will provide leadership and strategic direction for the company's regulatory affairs team. The role involves ensuring the registration of new products and line extensions, managing the life cycle of products, and aligning with commercial and global regulatory objectives.About the RoleLead a team of...
-
Regulatory Affairs Manager
1 month ago
Beijing, Beijing, China Bristol Myers Squibb Full timeTransform Your Career with Bristol Myers SquibbBristol Myers Squibb is a company that transcends the ordinary. We're not just another pharmaceutical company; we're a group of innovators, researchers, and problem solvers who are passionate about transforming patients' lives through science.A Day in the Life of a Regulatory Affairs Manager - China CMCAs a...
-
Regulatory Affairs Manager
1 month ago
Beijing, Beijing, China Pfizer Full timeAbout the RoleThis is an exciting opportunity for a seasoned Regulatory Affairs professional to join Pfizer's Global Regulatory Solutions (GRS) team in China. As a key member of our GRS CMC China team, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines across various jurisdictions.Key ResponsibilitiesServe as a...
-
Regulatory Affairs Specialist
2 months ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeRole Overview:We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GSK China. As a key member of our regulatory affairs team, you will be responsible for providing strategic and technical regulatory support to our line manager to ensure timely and high-quality submission and approval of our products in the...
-
Global Regulatory Affairs Leader
1 month ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeJob DescriptionWe are seeking a highly skilled Global Regulatory Affairs Leader to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd. As a key member of our organization, you will be responsible for providing strategic and technical regulatory support to our line manager.Key Responsibilities:Provide high-quality regulatory input and advice on...
-
Regulatory Affairs Manager for Takeda in Beijing
1 month ago
Beijing, Beijing, China Takeda Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Takeda in Beijing. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with drug administration and registration management regulations.Key ResponsibilitiesDevelop and implement product registration plans, coordinating with...
-
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeAbout the RoleWe are seeking a Senior Manager CMC Regulatory Affairs Professional to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd.Job SummaryThis role is responsible for providing strategic and technical regulatory input for new and established products, ensuring timely and high-quality CMC submissions and approvals in China.Key...
-
Regulatory Affairs Director
1 month ago
Beijing, Beijing, China Bayer Full timeOverviewBayer, a global leader in healthcare and agriculture, is seeking an experienced Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the successful registration and compliance of our chemical and biopharmaceutical products in China.
-
Regulatory Affairs Specialist
2 months ago
Beijing, Beijing, China AbbVie Full timeJob SummaryThis role requires a highly skilled and experienced professional to oversee the medical device regulatory compliance process in China. The successful candidate will be responsible for ensuring that all products meet the required regulatory standards and will work closely with the global team to achieve this goal.Key ResponsibilitiesDevelop and...
-
Regulatory Affairs Specialist
2 months ago
Beijing, Beijing, China Hologic, Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Hologic, Inc. This role will be responsible for establishing and maintaining registration plans for medical devices, forecasting and managing project budgets, and coordinating submissions to regulatory agencies.Key ResponsibilitiesDevelop and execute registration...
-
Regulatory Affairs Specialist
1 month ago
Beijing, Beijing, China Hologic, Inc. Full timeHologic, Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team.Job DescriptionThe ideal candidate will have more than 5 years of experience in regulatory affairs and related QA working experience in the medical device field.We are looking for someone who is familiar with imaging, surgical or IVD products and has a strong attention...
-
Beijing, Beijing, China Novo Nordisk AS Full timeAre you passionate about driving innovation in the pharmaceutical industry and transforming the treatment paradigm for chronic diseases? Novo Nordisk A/S, a leading international pharmaceutical company, is seeking an experienced Regulatory Affairs Supervisor to join its team.The ideal candidate will have a strong background in regulatory planning,...
-
Beijing, Beijing, China AbbVie Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Professional to join our team at AbbVie. As a key member of our medical device regulatory affairs group, you will play a critical role in ensuring compliance with regulations and securing product approvals.
-
Senior Regulatory Affairs Professional
4 weeks ago
Beijing, Beijing, China Novo Nordisk Full timeJob DescriptionWe are seeking a highly skilled Senior Regulatory Affairs Professional to join our team at Novo Nordisk.About the RoleThe successful candidate will be responsible for providing strategic regulatory guidance and support to ensure compliance with all relevant regulations and guidelines. This will include planning and executing regulatory...
-
Sr. Regulatory Affairs Supervisor
4 months ago
Beijing, China Novo Nordisk AS Full timeAre you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it...
-
Regulatory Affairs Professional
1 month ago
Beijing, Beijing, China Novo Nordisk Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novo Nordisk.Key ResponsibilitiesDevelop and implement regulatory plans to ensure compliance with relevant laws and regulations.Lead submissions and approvals for new products, license renewal, variations, and deregistration.Ensure regulatory compliance and system...
-
Head of General Affairs Strategist
4 weeks ago
Beijing, Beijing, China Astellas Pharma Inc. Full timeJob Description:Astellas Pharma Inc. is seeking a highly skilled Head of General Affairs Strategist to join our team in Beijing/Shanghai.About the Role:The Head of General Affairs Strategist will be responsible for developing and implementing departmental plans, managing office budgets, and ensuring a safe and comfortable working environment.Main...
-
China Reg CMC head
7 months ago
Beijing, China Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Senior Regulatory Affairs Manager
7 months ago
Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeRole Purpose ： To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Vaccine business by facilitating the submission and approval in a timely and high-quality manner. Key Accountabilities/Responsibilities ： Play the critical role of providing strategic and technical...
-
Regulatory Affairs Specialist
1 month ago
Beijing, Beijing, China Pfizer Full timeAbout UsPfizer is a global biopharmaceutical company that applies science and our global resources to deliver innovative therapies that extend and significantly improve lives. We are committed to becoming the premier, most respected biopharmaceutical company in the world.Job SummaryWe are seeking an experienced Associate Registration Manager to join our...
