Regulatory Affairs Manager-contract

Job type:
on-site
Start:
06/2015
Duration:
12 months
From:
Real Staffing
Place:
Dublin
Date:
08/10/2015
Country:
flag_no Ireland

Project description:
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This project is archived and not active any more.
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MAJOR ACTIVITIES AND RESPONSIBILITIES

Reporting to the Associate Director of Regulatory Affairs, the Regulatory Affairs Manager will:
  • Actively contribute to the development and implementation of regulatory strategy for assigned projects.
  • Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
  • Interface with external regulatory groups in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
  • Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
  • Provide regulatory support for clinical operations activities
  • Monitor company progress toward fulfillment of regulatory commitments.
  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
  • Review and communicate current & emerging regulatory requirements
  • Author and review SOPs; ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
  • Develop and maintain current regulatory knowledge.


Educational Requirements
  • Bachelor's degree in a scientific discipline or equivalent.


Professional Work Experience
  • Candidate must have at least 3 to 7 years of Regulatory experience in the pharma industry
  • Must have a solid understanding of FDA regulations and ICH guidance's, as well as a comprehension of the drug development process.
  • Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.