Regulatory Manager / Senior Regulatory Manager

March 29

pfm medical, inc.

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pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1

Medical Device Manufacturing

11 - 50

Description

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including 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 the 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 the 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 a representative of Global Regulatory Affairs at business development meetings

Requirements

• 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 • Computer literacy (MS Office/Office 365) • Fluent in English • Candidates must have regulatory affairs experience working for a Clinical Research Organization and have experience leading Clinical Submissions • Graduate, postgraduate (preferred) • Possesses a basic understanding of financial management (preferred)

Benefits

• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities • Ability to understand clinical and pre-clinical study results, and to help in their interpretation for regulatory positions and strategy • Availability for domestic and international travel including overnight stays • Competitive salary based on experience and qualifications