Regulatory Affairs Manager-contract

Job type:
12 months
Real Staffing
flag_no Ireland

Project description:
This project is archived and not active any more.
You will find vacant projects in our project database.

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.