Job Description:
Precision for Medicine is seeking a Regulatory Manager to provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.
The successful candidate will ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
Key Responsibilities:
* Regulatory Guidance: Provides regulatory strategy and development guidance throughout the clinical development life cycle.
* Submission Preparation: Compiles, coordinates, and reviews applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
* Document Development: Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
* Representative Role: Serves as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.
* Leadership: Works within a project team, and where necessary, leads project for the region or globally.
Qualifications:
* Bachelor's Degree: Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline.
* Regulatory Experience: 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level.
Preferred Qualifications:
* Financial Management: Possesses basic understanding of financial management.
Other Requirements:
* Regulatory Background: Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions.
* Knowledge of Regulations: Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
* Clinical Trials: Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy.
* Travel: Availability for domestic and international travel including overnight stays.
* Communication Skills: Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities.
About Precision for Medicine:
Precision for Medicine is a precision medicine Clinical Research Organization. We combine novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.