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Precision for Medicine is seeking a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials. The role involves ensuring timely preparation of quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager will coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.
- Providing regulatory guidance throughout the clinical development life cycle
- Compiling, coordinating, and reviewing applications to Regulatory Authorities
- Developing and reviewing documents intended for submission to Regulatory Authorities and/or Ethics Committees
- Serving as a representative of Global Regulatory Affairs at project team meetings
- Overseeing and coordinating Regulatory Affairs Specialists
- Maintaining project plans and regulatory intelligence tools
- Assisting in the development of Regulatory Affairs Specialists
- Providing input into regulatory strategy and timeline development
- Participating in corporate quality initiatives
- Keeping abreast of laws, regulations, and guidelines governing drug development
- Providing ICH GCP guidance, advice, and training
- Serving as a representative of Global Regulatory Affairs at business development meetings
- Bachelor's degree in a scientific or healthcare discipline
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
- Computer literacy (MS Office/ Office 365)
- Fluent in English
- Regulatory affairs experience working for a Clinical Research Organisation
- Experience leading Clinical Submissions
- Informed knowledge of all aspects of the drug development process
- Knowledgeable of clinical trials methodology
- Knowledge and expertise with relevant regulations and guidance
- Remote work opportunity
- Opportunity to work on ground breaking cancer therapies
- Valued input and ideas
- Positive impact on the company
Precision for Medicine
Precision for Medicine is dedicated to enhancing clinical research and development. They achieve this by providing specialized services that integrate scientific understanding with advanced analytical platforms. They help optimize clinical trials, accelerate drug development, and enable a deeper understanding of disease mechanisms, ultimately aiming to improve patient outcomes through precision medicine approaches and tailored therapeutics.