Regulatory and start up specialist / Senior

August 22

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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

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Act as SME for collection and maintenance of site level critical path to Site Activation data points. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. • May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. • May mentor staff on local study start-up regulations, submissions, and internal procedures.

Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • 5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Excellent communication and organizational skills are essential. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and for non-English speaking countries the local language of country where position based. • Ability to prioritize workload to meet deadlines.