Senior Regulatory Affairs Specialist
3 weeks ago
As a Senior Regulatory Affairs Specialist at GlaxoSmithKline, you will play a crucial role in ensuring the development and execution of global and/or regional regulatory strategies for assigned assets. This position requires close collaboration with cross-functional teams to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data.
About You
To be successful in this role, you should have a Bachelor's degree in biological or healthcare science and experience in the drug development process within regulatory affairs. An Advanced Scientific Degree (PhD, MD, PharmD) is highly desirable. Additionally, you should possess the ability to develop necessary specialist knowledge for the product in a specific oncology disease area and creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
Key Responsibilities
Some of your key responsibilities as a Senior Regulatory Affairs Specialist will include being accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans. You will collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets. Your role will also involve working closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data.
Salary Information
This role offers an estimated salary of $140,000 - $170,000 per year, depending on qualifications and location.
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