Director, CMC Regulatory BioPharm Lead
4 weeks ago
Job Description:
GSK is seeking a highly skilled Director, CMC Regulatory BioPharm to join our team. As a key member of our Global Regulatory Affairs organization, you will be responsible for leading strategic CMC regulatory activities for investigational and/or early commercial biological products.
About the Role:
- Lead CMC Regulatory Activities: Develop and implement CMC regulatory strategies to ensure compliance with regulatory requirements for biopharmaceutical products.
- CMC Regulatory Strategy: Collaborate with cross-functional teams to develop and execute CMC regulatory strategies to support global project and key strategic business initiatives.
- Regulatory Leadership: Provide regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
- Problem Solving: Direct project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable.
- Communication: Serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces.
Requirements:
- Education: Bachelor’s degree in a Biological sciences area.
- Experience: 7+ years of direct CMC Regulatory experience, with experience leading key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals.
- Skills: Strong knowledge of regulatory requirements for biopharmaceutical products, strategic thinking, leadership, communication, and problem-solving skills.
About GSK:
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). 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.
Why GSK?
At GSK, we are committed to making a positive impact on society. We are a company that values diversity, equity, and inclusion, and we strive to create a workplace where everyone feels welcome and valued. If you are passionate about making a difference in the lives of patients and customers, and you have the skills and experience to succeed in this role, we encourage you to apply.
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