Director of Global Regulatory Affairs
14 hours ago
Lead Regulatory Strategy for RNA Vaccines
We are seeking a highly skilled Director, Global Regulatory Affairs to lead our regulatory strategy for RNA vaccines. As a key member of our team, you will be responsible for developing and implementing regulatory plans to ensure compliance with global regulations and guidelines.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with global regulations and guidelines.
- Lead cross-functional teams to develop and submit regulatory documents to FDA and other regulatory agencies.
- Provide regulatory expertise to support the development and commercialization of RNA vaccines.
- Collaborate with internal stakeholders to ensure regulatory alignment with business objectives.
- Stay up-to-date with changes in regulatory guidelines and rules, and communicate their impact on regulatory strategy.
Requirements:
- 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 scientific basis for clinical development, endpoints, and product CMC.
- Experience as liaison with US FDA.
Preferred Qualifications:
- Experience at a large pharmaceutical/vaccines company.
- Excellent communication skills.
- Experience working successfully in a matrix environment.
- Strong leadership 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).
Why GSK?
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. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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