Regulatory Manager

4 days ago

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives across business units • Keeps abreast and continually expand knowledge of laws, regulations and guidelines • Provides ICH GCP guidance, advice and training to internal and external clients • Serve 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