Regulatory Affairs Manager

in Levittown, PA

Job #:533976

Practice Area: IT

Date Posted: 09/11/2020

Share this job  

Job Title:  Regulatory Operations Manager

Location:  Levittown, PA

Industry: Pharmaceutical

Terms:  Direct-Hire

Compensation (optional): 

Requirements:  5 to 7+ years of experience in the pharmaceutical industry including 3 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions.

Job Summary:

One of our client, a leading international pharmaceuticals company with a growing presence in the global generics market is seeking for Regulatory Operations Leader responsible for managing and guaranteeing the processes of maintenance and registration of new products and state wholesaler licenses as required from the FDA and other regulatory agencies. Submit electronic documentation through Electronic Submissions Gateway. These are direct-hire opportunities for a Regulatory Operations Leader to manage the preparation of all types of FDA submissions including post approval changes and PLAIRs and a Sr. Associate to coordination, preparation, review and submission of high quality regulatory filings.

Job Responsibilities:

  • Provide strategic regulatory support to all functional groups.
  • Create, organize and manage the preparation of all types of FDA submissions including post approval changes and PLAIRs.
  • Preparation and submission of the requisite Annual Reports, and PADERS for approved ANDA's.
  • Respond to queries from FDA. Develop a strong relationship with the FDA.
  • Advise the Company on relevant new and existing regulatory strategies, risks and compliance requirements and provide regulatory expertise, advice and support for ANDA, NDA 505(b)(2) submissions.
  • Assess project risks, and where appropriate, recommend possible contingency plans, and strategies to management in order to mitigate regulatory risks
  • Assess and justify the appropriate category for post-approval change classifications.
  • Advise the team on bioequivalence/clinical strategies for more complex generic formulations.
  • Independently review and provide feedback to the marketing and business development team. Provide regulatory input on selection of products for development
  • Responsible for implementing life-cycle remediation techniques and creating baseline submissions for applications with damaged eCTD life-cycles. Other responsibilities include sANDA Applications, Annual Reports, and Annual/Quarterly PADERs.
  • Biannually re-certify all drug listings in accordance with 21 CFR 207.57 as well as submission of FDA Establishment Registrations and GDUFA Self-Identifications. Responsible for maintaining all state licenses along with assisting with import clearance.

Job Requirements:

  • At least 5 to 7 years of experience in the pharmaceutical industry including 3 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions.
  • Knowledge of filing and approval process for generic drug products. Thorough understanding of ICH and FDA guidelines
  • Experience in dealing with the FDA – OGD is desirable.
  • Experience writing and assembling the supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions. Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs is a plus.
  • Strong understanding of R&D processes required for ANDA submissions.
  • Knowledge of regulations/best practices for Rx drug storage/distribution including familiarity with the upcoming track and trace/ePedigreee requirements.
  • Knowledge of product development milestones and compliance requirements.
  • Proficient with Adobe, eCTD software and Microsoft Office applications.

Must Haves

  • Publishing experience with eCTD systems including Module V compilation
  • Knowledge and experience with state licensing and drug reporting requirements
  • Create GDUFA Cover sheets
  • Submit compiled sequences thru ESG gateway
  • GDUFA Facility registration renewal
  • Experience specifically with PharmaReady software
  • Personally holds CDR in any U.S. states
  • Minimum CMC experience

Apply Now