Regulatory Manager

4 days ago

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000

💰 $35.2M Venture Round on 2021-03

Description

• The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials • Ensures timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations • Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees • Maintains a current knowledge of regulations and guidance documents, providing analysis to project teams • Supports and enhances Precision for Medicines corporate Regulatory function • Provides regulatory guidance throughout the clinical development life cycle • Compiles, coordinates and reviews applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities • Serves as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and leads project as necessary • Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets • Maintains project plans, project trackers and regulatory intelligence tools • Assists in development of Regulatory Affairs Specialists and other operational area staff • Provides input into regulatory strategy and timeline development • Participates in maintaining and executing on the corporate quality initiatives • Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development • Provides ICH GCP guidance, advice and training to internal and external clients • Serves as representative of Global Regulatory Affairs at business development meetings

Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • Computer literacy (MS Office/ Office 365) • Fluent in English • 5+ years or more relevant regulatory affairs experience • 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) • Ability to understand clinical and pre-clinical study results • Knowledgeable of clinical trials methodology • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel including overnight stays

Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation