Head of Regulatory Affairs China

7 days ago

Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full time
Job Purpose:

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.
Requirements:
  • 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.
  • 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?

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).

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.

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