Head of Regulatory Affairs Director
4 weeks ago
As the Head of Regulatory Affairs, 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 and manage the Regulatory Affairs team to achieve business objectives.
- Develop and implement regulatory plans and strategies to align with local, regional, and global objectives.
- Build and maintain professional relationships with internal and external stakeholders, including regulatory authorities and trade associations.
- Ensure compliance with government laws and regulations, as well as corporate standards.
- Oversee the governance and oversight of regulatory processes to ensure timely and quality delivery.
- Set objectives, manage team performance, and hold team members accountable for delivery.
- Train, mentor, and supervise team members to enhance their skills and knowledge.
- Enhance the team's culture and performance to align with GSK's values and objectives.
- Bachelor's degree or advanced degree in Life Sciences.
- At least 15 years of experience in the pharmaceutical industry, with extensive experience in Regulatory Affairs and management of 2nd line leaders.
- Demonstrated experience in taking products through early and late development, registration, and post-marketing license maintenance.
- Strong knowledge of the China regulatory framework and requirements, as well as international regulatory processes.
- Experience in advocating to shape regulatory environments.
- Leadership and team management skills.
- Strong matrix leadership and collaboration skills.
- Excellent written and verbal communication skills.
- Ability to influence at the global level.
- Good commercial awareness and understanding of how regulatory matters impact business objectives.
GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. Our focus is on the science of the immune system and the use of new platform and data technologies. We invest in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
We are committed to making GSK a place where people can thrive. We want our employees to feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves, feel welcome, valued, and included. Where they can keep growing and look after their wellbeing.
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