Regulatory Manager / Senior Regulatory Manager

March 29

pfm medical, inc.

WebsiteLinkedInAll Job Openings

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

• The Regulatory Manager (RM) provides 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 organized, quality regulatory submissions in compliance with applicable regulations. • 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

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 • Graduate, postgraduate • Possesses basic understanding of financial management • Candidates must have regulatory affairs experience working for a Clinical Research Organisation, Biotech or Pharmaceutical company and have experience leading Clinical Submissions • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and 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 • Availability for domestic and international travel including overnight stays