Regulatory Affairs Strategist
1 month ago
At GlaxoSmithKline, we are seeking an experienced Regulatory Affairs Director to drive growth in oncology by developing and executing global and regional regulatory strategies.
- Develop robust regional regulatory strategies aligned with the Medicines Development Strategy and Integrated Asset Plan.
- Engage in matrix working within GSK, including senior management, and represent GSK with local regulatory agencies to secure optimal labelling based on available data.
- Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.
- Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
Estimated Salary: $120,000 - $180,000 per annum
To be successful, you will need a Bachelor's degree in biological or healthcare science and extensive experience in pharmaceutical industry Regulatory Affairs. Proven track record of interactions with Health Authorities and ability to lead development, submission and approval activities in different region(s) globally.
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