Regulatory Manager

financial management

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

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

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

Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied

Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development

The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations.

The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.

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, pediatric planning, and marketing applications.

Also provides strategic regulatory input as required.