Regulatory Affairs Specialist (ANDAs) 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 ANDAs 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 Generic New Drug Applications (ANDAs) according to FDA regulations.
- Develop and assess strategies for regulatory approvals for ANDAs by providing input from product development through commercialization.
- Prepare controlled correspondence to FDA.
- Provide technical writing for ANDAs, supplements, amendments etc.
- Prepare responses to information requests, amendments, complete responses
- Prepare and maintain a correspondence log for each ANDA submission.
- Provide regulatory input for the product development and submission process for ANDA submissions.
- Review documents and interact with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation to ensure accurate reporting to FDA.
- Track ANDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.
- Maintain and ensure all ANDA documentation is filed properly.
- 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.
- Provide oversight of clinical studies in support of ANDA submissions.
- Education: BS or higher degree in engineering, science, health care or similar required.
- Experience: 10+ years regulatory experience with at least 5 years regulatory experience in Generic 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.