Sr. Regulatory Affairs Associate

in Levittown, PA

Job #:533977

Practice Area: Creative

Date Posted: 09/22/2020

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Job Title: Sr. Regulatory Affairs Associate

Location:  Levittown, PA

Industry: Pharmaceutical

Terms:  Direct-Hire

Compensation (optional): 

Requirements:  3-5 years Pharmaceutical industry experience in Regulatory Affairs (ANDA/ 505 (b) (2)) and maintenance of approved applications 

Job Summary:

One of our client, a leading international pharmaceuticals company with a growing presence in the global generics market is seeking for Sr. Regulatory Affairs Associate involves coordination, preparation, review and submission of high quality regulatory filings in compliance with regulatory guidelines and applicable laws with minimal supervision. These are direct-hire opportunities for a Sr. Associate to coordination, preparation, review and submission of high quality regulatory filings and a Regulatory Operations Leader to manage the preparation of all types of FDA submissions including post approval changes and PLAIRs.

Job Responsibilities:

  • Facilitate and organize the compilation of ANDA, 505 (B)(2), Amendments, Supplements, PLAIRs, Annual Reports, and Periodic safety reports.
  • Prepare and review all submissions for completeness and correctness in compliance with SOPs and current regulatory formats and requirements.
  • Assist in developing and training other RA Associates
  • Assist in preparation, proof reading, review, approval, of labeling
  • Participate in regulatory strategies and plans for products under development
  • Update Regulatory Affairs departmental SOPs to be current with regulatory and industrial standards
  • Evaluate change controls and assess impact of the changes to the approved applications and/or the filing marketing authorization and determine filing requirements
  • Keep up to date on FDA, ICH, EU regulatory requirements
  • Assess and justify the appropriate category for post-approval change classifications.

Job Requirements:

  • BS or higher degree in scientific or technical discipline
  • 3-5 years Pharmaceutical industry experience in Regulatory Affairs (ANDA/ 505 (b) (2)) and maintenance of approved applications 
  • Up to date knowledge of current regulatory guidance (FDA, ICH, and EU) specifically related to submissions, registrations, and labeling changes.
  • Proficient with Adobe, eCTD software and Microsoft Office applications.

Must Haves

  • Generics Industry Experience
  • Experience preparing ANDA submissions
  • Experience in reviewing change controls and evaluate change as per FDA guidelines.
  • Experience preparing annual reports and periodic adverse drug experience reports.
  • Experience in review and respond to FDA deficiencies.
  • Experience in submitting Supplements and any other post approval submissions
  • Review Labeling as and when required
  • Experience in reviewing documents received from cross functional teams and provide guidance as per regulations.
  • Interact with external third parties as required for the completion of CMO projects.
  • Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Maintains Regulatory Databases

GOOD TO HAVE:

  • Med Device or Diagnostics Industry Experience
  • Experience preparing NDAs, PMAs, 510(k)s
  • Experience with 505(b)(2)s including Pre-INDs and INDs
  • Experience with Module V of eCTD

Job Key Words:

Regulatory Publisher, Regulatory Affairs Associate, Sr. Regulatory Operations Lead, managing processes of maintenance and registration of new products, state licenses, FDA, regulatory agencies. Submit electronic documentation, Electronic Submissions Gateway, strategic regulatory, FDA submissions, post approval, PLAIRs, PADERS, approved ANDA's, ANDA, NDA 505(b)(2) submissions, regulatory risks, post-approval change, bioequivalence/clinical strategies for more complex generic formulations, regulatory input on selection of products for development, submissions for applications with damaged eCTD life-cycles, sANDA Applications, Annual Reports, and Annual/Quarterly PADERs, 21 CFR 207.57 as well as submission of FDA, GDUFA, regulatory, pre and post approval pharmaceutical FDA submissions, filing and approval process for  generic drug products, OGD, CTD format and eCTD submissions, ANDAs, track and trace/ePedigreee requirements, Adobe, eCTD software and Microsoft Office applications, Publishing experience,  eCTD systems, Module V compilation, state licensing and drug reporting, Create GDUFA Cover sheets, ESG gateway, GDUFA Facility registration renewal, PharmaReady, CDR, CMC

Frequently Asked Questions:

  • Benefits?  Yes. Compatible benefit provided by the company
  • Remote Workers?  Remote till January 2021
  • Visa Sponsorship?  No Visa Sponsorship provided
  • Corp-to-Corp?  NO, this is a direct-hire opportunity

How to Apply:

For immediate attention please apply online at rose.chu@ettaingroup.com  and send a text message or leave a voicemail for (Rose Chu) at (215-317-2999)

ettain group is the Talent Solutions Company dedicated to employment opportunities in Technology, Healthcare IT, Digital, Professional, and Government. Since 1996 we’ve helped the most talented professionals in the industry capture the in-demand roles that align with their career goals. We are your long-term career partner and will not only work to find you an opportunity now but will actively work to re-engage you on your next assignment. Top employers and highly skilled talent throughout the U.S. select ettain group for an unparalleled recruitment experience, which has earned us ClearlyRated’s Best of Staffing Diamond Awards for both Talent & Client Satisfaction for 9 consecutive years, an honor achieved by less than 2% in our industry. To learn more about ettain group visit www.ettaingroup.com. To explore more job opportunities with ettain group, visit www.jobs.ettaingroup.com/job-board.


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