Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team.

As a Regulatory Manager, you will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

Essential functions of the job include but are not limited to:

Provides regulatory guidance throughout the clinical development life cycle

Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required

Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards

Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Works within a project team, and where necessary, leads project for the region or globally

Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs

Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

Assist in development of Regulatory Affairs Specialists and other operational area staff, as required

Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information

Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.

Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval

Provides ICH GCP guidance, advice and training to internal and external clients

Serve as representative of Global Regulatory Affairs at business development meetings

The ideal candidate will have the following:

Minimum Required:

Bachelors degree, or equivalent experience, ideally 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

Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised 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.

Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical Submissions

Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy