Global Regulatory Affairs Director
4 days ago
We are seeking a highly experienced and skilled Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and executing regulatory strategies for assigned assets across all stages of product development.
Key Responsibilities- Develop and execute regulatory strategies for assigned assets, ensuring compliance with internal GSK processes and regional regulatory requirements.
- Collaborate with cross-functional teams, including R&D, Medical, and Commercial, to secure best possible labeling commensurate with available data.
- Provide strategic regulatory input for all development stages of projects/products within a given product portfolio.
- Liaise closely with other GRA teams, such as non-clinical, CMC, Labeling, and AdPromo, through the Regulatory Matrix Team (RMT).
- Lead regulatory interactions and review processes in local regions, serving as the point of contact to regulatory agencies.
- Ensure compliance with regional requirements at all stages of product life, from early development to life cycle activities.
- Advocate scientifically sound approaches persuasively to senior leaders in GSK and at health authorities.
- Assess potential in-license vaccines.
- Bachelor's degree in biological or healthcare science.
- Five or more years of experience in regulatory affairs, including all phases of the drug development process.
- Three or more years of experience leading regional development, submission, and approval activities in local regions.
- Master's or Ph.D. in biological or healthcare science.
- Proven track record of successful relationships with health authorities.
- Extensive knowledge of clinical trial and licensing requirements in regions and globally.
- Sound knowledge of relevant areas of medicine or proven track record of developing product/therapeutic knowledge in new areas.
- Significant external network in the pharmaceutical industry and recognized as an expert in regulatory affairs.
- Able to deputize for GRL for assigned assets.
- Solid experience in procedural/registration US regulatory affairs, including as US authorized agent.
- Knowledge of IND and BLA regulations and US regulations pertinent to product development and licensure/post-licensure.
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