Regulatory Affairs Specialist (NDAs) 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 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 (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 NDAs, supplements, amendments etc.
- Prepare responses to information requests, amendments, complete responses
- Prepare and maintain a correspondence log for each NDA submission.
- Provide regulatory input for the product development and submission process for NDA 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 NDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.
- Maintain and ensure all NDA 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 NDA 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 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.