Director of Regulatory Affairs, CMC BioPharmaceuticals
3 weeks ago
Overview
GSK is seeking a highly skilled Director of Regulatory Affairs, CMC to lead key strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals. As a key member of the Global Regulatory Affairs team, you will provide strategic direction and guidance on global project and key strategic business initiatives.
Key Responsibilities
- Lead CMC regulatory activities for investigational, late development and/or early commercial GSK products.
- Develop and execute CMC regulatory strategies to support major inspections and quality incidents.
- Collaborate with cross-functional teams to ensure timely preparation and submission of regulatory documents.
- Identify and mitigate risks associated with submission data and information packages.
- Provide strategic direction and guidance to senior management on CMC regulatory matters.
Requirements
- Bachelor's degree in a biological sciences area.
- 7+ years of direct CMC Regulatory experience.
- Experience leading key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals.
- Experience working in large enterprise companies leading complex projects.
- Experience working with new drug applications in the US or EU.
Preferred Qualifications
- Advanced biological sciences degree.
- 5+ years of CMC Regulatory project leadership experience with biological medicines.
- Ability to demonstrate flexible thinking and high resilience in the workplace.
- Ability to work with frequent changing priorities within a fast-paced work culture.
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).
Why Join Us
At GSK, we want 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. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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