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Director, Global Regulatory Affairs
2 months ago
We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.
Key Responsibilities- Develop and implement regulatory strategies to support the development and launch of mRNA vaccines.
- Provide regulatory expertise and guidance to cross-functional teams to ensure compliance with regulatory requirements.
- Lead the preparation and submission of regulatory documents, including INDs, BLAs, and Q&A documents.
- Collaborate with internal stakeholders to develop and implement regulatory plans and strategies.
- Stay up-to-date with changes in regulatory guidelines and rules, and provide guidance on their impact on our regulatory strategy.
- Develop and maintain relationships with regulatory agencies, including the FDA.
- Provide input to and manage regulatory activities to obtain marketing authorizations for new vaccines.
- Lead multidisciplinary teams to compile, write, and review high-quality project-specific regulatory documents.
- Bachelor's degree and 10+ years of experience in regulatory affairs, or advanced degree and 5+ years of experience.
- Experience in scientific and regulatory affairs in all stages of product development.
- Experience in clinical regulatory affairs and CMC regulatory affairs for pre-licensed and licensed biologic products or vaccines.
- Knowledge of IND and NDA/BLA regulations and US regulations pertinent to product development and licensure.
- Knowledge of the scientific basis for clinical development, endpoints, and product CMC.
- Experience as a liaison with the FDA.
- Experience at a large pharmaceutical or vaccines company.
- Excellent communication skills.
- Experience working successfully in a matrix environment.
- Strong leadership skills.
GlaxoSmithKline is a global biopharmaceutical company that is committed to improving the lives of patients around the world. We are a leader in the development and manufacture of vaccines, medicines, and consumer healthcare products. Our mission is to unite science, technology, and talent to get ahead of disease together.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.
