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Head of Regulatory Affairs China
1 month ago
As the Head of Regulatory Affairs in China, you will provide strategic direction and leadership to the GSK China Regulatory Affairs team. Your primary focus will be on ensuring the registration of new products and line extensions, as well as managing the life cycle of products in line with commercial and global regulatory objectives.
Key Responsibilities:- Lead the Regulatory Affairs team in China.
- Align regulatory plans and resources with local, regional, and global objectives.
- Develop and maintain professional relationships with internal and external stakeholders.
- Ensure compliance with government laws and regulations, as well as corporate standards.
- Oversee the governance and oversight of regulatory obligations and expectations.
- Set objectives, manage team performance, and hold team members accountable for delivery.
- Train, mentor, and supervise members of the Regulatory Affairs team.
- Enhance the team's culture in alignment with the GSK culture.
- Develop and enhance Policy, Advocacy, and Intelligence activities and network.
- Bachelor's degree or Advanced degree in Life Sciences.
- At least 15 years of experience working in the pharmaceutical industry with direct 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, as well as international regulatory processes.
- Experience in advocating to shape the regulatory environment.
- Leadership of big teams with empowerment and accountability.
- Strong matrix leadership and ability to work collaboratively with cross-functional teams.
- Excellent written and verbal communication skills.
- Ability to influence at the global level.
- Good commercial awareness and understanding of how the business works.
- Excellent eye for detail.
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. 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).
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.
