Location: Boston, MA or Remote (East Coast USA)
Our client is a young but growing organization that are now ready to welcome their first key Regulatory Affairs hire to build out Regulatory in relation to the company and their diverse portfolio. As a company, our client is at a key point of their growth and development, with investigational drug development programs across North America, Europe, and Asia, which makes it a fantastic time to join them. Although their office location in the USA is in Boston, the client is very happy for the right person to work remotely as long as they are on the East Coast (central time zone locations also work).
We are looking for a skilled and experienced individual within the world of Regulatory Affairs to collaborate across functional areas with both internal and external stakeholders to implement global regulatory strategies. You will work with and guide multiple stakeholders to ensure that the development strategy is aligned with each countries regulatory requirements from IND filling through to NDA submission in the USA + similar milestones globally.
Skills & Experience:
10+ years’ Regulatory experience
Experience coordinating regulatory strategies and tactics with clinical development and business goals and objectives.
Proven ability to maintain technical files and prepare and submit documents to regulatory agencies compliant with all country specific regulations.
Ability to explain regulatory requirements to project teams / colleagues, plus foresee and avoid potential pitfalls.
Ability to demonstrate an understanding of FDA, EMA and NMPA requirements and quality system requirements.
Ability to provide insight into Regulatory Affair’s impact on business outcomes.
Experience with early phase development of new molecular entities in metabolic diseases and/or oncology is desirable but not essential.
If this sounds like the next step in your career then please apply today in order for Chris Sinclair at RBW Consulting to review your profile and be in touch to discuss this in more detail.
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