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.

Why you?

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：

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[email protected]联系我们。