Regulatory Affairs Associate

Company: Alpha Consulting
Location: Plainsboro
Posted on: May 23, 2023

Job Description:

REGULATORY AFFAIRS ASSOCIATE PLAINSBORO, NJ Remote or Hybrid/Plainsboro, NJ. Hourly pay range depending on experience is 36.63 to 38.00. TOP 3 MUST HAVES:

• Experience with submission work in VaultRim.
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports).
• Knowledge about Module 1 documents. Project Description:
  • Assist more experienced regulatory personnel.
  • Functions in accordance with supervisor's guidance.
  • Reports to the Manager or Director on assigned projects.
  • Works with other project team members, including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs.
  • SUBMISSIONS: in accordance with supervisor's requirements & guidance:
    • Coordinate document submission.
    • Review documents.
    • Obtain documents/information for regulatory submissions from various functional areas and check for errors, missing information, legibility, translations, etc.
    • Review information from local & NNAS contributing departments and provides comments to assure that documents are accurate and complete and comply with FDA regulations.
    • Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor's requirements and guidance.
    • Advise stakeholders of submission completion.
    • FDA COMPLIANCE:
      • Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions.
      • Assist Manager/Director in review of labeling for marketed products and new products as assigned.
      • FDA INTERACTIONS:
        • Prepare ROCs for routine FDA contacts.
        • Prepare drafts of routine correspondence.
        • Assist in preparation of regulatory documents.
        • Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.
        • PRODUCT DEVELOPMENT SUPPORT:
          • Assist more senior personnel in managing projects.
          • Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal, and memoranda where applicable.
          • Use of templated correspondence as appropriate, ensuring that all new information is correct.
          • As requested, find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.
          • As assigned, participate in project teams.
          • DEVELOPMENT OF PEOPLE:
            • May help orient and mentor new associates.
            • Ensure that 3P form with annual goals and measurements is consistent with the priorities of the business.
            • Manage the application and communication of all client policies, procedures, and company Way of Management.
            • Ensure that the IDP form includes completed Learning and Aspiration plans and are in place to enable the achievement of goals and capability to assume increased levels of responsibility. Required Skills:
              • Bachelor's Degree required; Life Science preferred.
              • Minimum of 3 years' experience required (Pharmaceutical industry, laboratory, or clinical research position).
              • Intermediate proficiency in Microsoft Office Suite required.
              • Excellent written skills.
              • Effective personal time management.
              • High commitment to quality of all assigned projects.
              • Strong detail orientation.
              • Strong interest in continuous improvement and professional development.
              • Commitment to regulatory affairs profession.
              • Experience with submission work in VaultRim .
              • Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports).
              • Knowledge about Module 1 documents . This 12+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting, Trenton , Regulatory Affairs Associate, Other , Plainsboro, New Jersey