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
- 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.