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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 and coordinating regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.
Responsibilities include:
- Providing regulatory guidance throughout the clinical development life cycle.
- Compiling, coordinating, and reviewing applications to Regulatory Authorities.
- Developing and reviewing documents 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.
- Staying updated on laws, regulations, and guidelines governing drug development.
- Providing ICH GCP guidance and training.
- Serving as a representative of Global Regulatory Affairs at business development meetings.
Requirements:
- 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).
- Fluency 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.
- Availability for domestic and international travel.
Precision for Medicine offers:
- Opportunity to provide input and have ideas valued.
- Chance to impact positive change for 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.