
Strategic Regulatory Leader
21 hours ago
The Director of Regulatory Affairs will provide strategic leadership to teams responsible for regulatory submissions worldwide.
This includes providing regulatory strategy and support for all regulatory and ethics submissions in relation to Clinical Trials and drug development, including Health Authority interaction, attending meetings, and provision of strategic regulatory support to other departments, project teams, and committees.
The Director of Regulatory Affairs will also support the development of the Regulatory department and enhance corporate Regulatory functions, as well as facilitate business development and proposals in this area.
Required Skills and Qualifications- Post Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry
- Extensive and broad knowledge and experience of all aspects of drug development process, including subject matter expertise in regulations and guidelines (including but not limited to: NA, EMA, APAC, national authorities and IHC/GCP/GMP)
We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies.
You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
OthersOur team is committed to fostering a culture of mutual respect and collaboration.
As a member of our team, you will be encouraged to take ownership of your work and contribute to the growth and success of the organization.
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