Regulatory Affairs Manager
Company: Integrated Resources, Inc.
Location: Jersey City
Posted on: May 16, 2022
Hours Per Week: 35 hours/ week
- Contributes to preparation of high-quality regulatory
submissions by helping to organize cross-functional activities
pertaining to the regulatory function, including the development of
meeting requests, timelines, and compilation of briefing documents
intended for submission to regulatory authorities.
- Participates and presents in various meetings (e.g., clinical
study operation meetings, other regulatory meetings
- Works with CROs, reviews and approves regulatory packages.
Informs clinical supply for IMP release. Compiles Investigator CV
and Form 1572 for FDA submission.
- Liaises with external CROs and other vendors to support
external safety data processing.
- Drafts cover letter and FDA forms for Investigator submissions
- Ensures compliant documentation is received prior to release of
- Ensures compliance and availability of documentation during QA
and FDA audits as required.
- Provides logistical support preparation for meetings with the
FDA/other regulatory agencies.
- Stays abreast of industry news through news feeds, publications
and industry events and conducts/ analyzes regulatory research to
better understand current competitive landscape and trends.
Educates internal stakeholders on same.
- Provides regulatory support to other MTDA departments and
multifunctional teams to ensure compliance with regulatory
requirements for content and format of paper/electronic regulatory
submissions and documentation.
- Independently makes decisions regarding work processes,
operational plans or schedules in order to achieve department and
project objectives. Escalates more complex issues, as required, to
the Associate Director.
- Maintains regulatory dossiers in compliance with
- Interacts with global project teams, as required, to ensure the
timely preparation and receipt of information required for
regulatory submissions in other global regions.
- Contributes to process improvement initiatives across the
- Bachelor's degree in scientific discipline or related field
- Minimum of 5-7 years of experience in the industry with at
least 3-5 years in Regulatory Affairs.
- Experience working in a multicultural, multi-lingual
- In-depth knowledge of the regulatory submissions process and
related FDA regulations. Familiarity with international regulatory
bodies is a plus.
- Strong organizational skills coupled with a sense of urgency;
proven ability to manage processes to timeline.
- Excellent interpersonal and cross-functional collaboration
- Strong attention to detail; a track record of error-free FDA
- Competency in MS Office (Word, Excel, PowerPoint, Outlook) and
- Willingness to engage in light travel (up to 5%).
Keywords: Integrated Resources, Inc., Jersey City , Regulatory Affairs Manager, Executive , Jersey City, New Jersey
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