Regulatory Affairs Specialist - ANDA/NDA

  • location: Allentown, PA
  • type: Permanent
  • salary: $90,000 - $110,000 per year
easy apply

job description

Regulatory Affairs Specialist - ANDA/NDA

job summary:
Senior Regulatory Affairs Specialist - Generics and/or Branded will be responsible for preparing submissions for New Drug Applications according to FDA regulations. They will also develop and assess strategies for regulatory approvals for ANDA/NDAs by providing input from product development through commercialization.

location: Allentown, Pennsylvania
job type: Permanent
salary: $90,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors
  • Prepare submissions for New Drug Applications (ANDAs/NDAs) according to FDA regulations.
  • Develop and assess strategies for regulatory approvals for NDAs by providing input from product development through commercialization.
  • Prepare controlled correspondence to FDA.
  • Provide technical writing for ANDA/NDA, supplements, amendments etc.
  • Collect and organize necessary documentation to be included in ANDA/NDA submissions, reports, etc.
  • Prepare the Quality Overall Summary and all eCTD module submission documentation for ANDA/NDA filings.
  • Prepare responses to information requests, amendments, complete response letters, supplements, etc. associated with ANDA/NDA submission and submit to FDA.
  • Review ANDA/NDA submission documentation to ensure that all current FDA guidelines are met.
  • Prepare and maintain a correspondence log for each ANDA/NDA submission.
  • Coordinate eCTD submission of NDA's between client and any outside contracted company.
  • Provide regulatory input for the product development and submission process for ANDA/NDA submissions.
  • Prepare annual reports for ANDA/NDA in accordance with 21 CFR 314.81.
  • Review documents and interact with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation to ensure accurate reporting to FDA.
  • Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.
  • Track ANDA/NDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.
  • Maintain and ensure all ANDA/NDA documentation is filed properly.
  • Maintain and manage product specific checklists to ensure that all required documentation and information is available, accurate and complete for submission.
  • Assist in the preparation and submission of required post approval reports such as quarterly and annual periodic adverse drug experience reports, post commitment requirements, etc.
  • Maintain current knowledge of FDA regulations and guidance's pertaining to changes to approved NDA regulatory applications.
  • Provide oversight of clinical studies in support of ANDA/NDA submissions.
  • Education: BS or higher degree in engineering, science, health care or similar required.
  • Experience: 5+ years regulatory experience with at least 5 years regulatory experience in Pharmaceuticals, including demonstrated experience in preparing successful FDA 510(k) submissions.
  • Strong working knowledge of FDA pharma regulatory requirements.
  • Skills: Proficient in Microsoft Office.
  • Must possess strong oral and written communication skills
skills: NDA, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

easy apply

get jobs in your inbox.

sign up

related jobs