This position will assist with the preparation and submission of ANDAs, Amendments, Supplements and Annual Reports to appropriate regulatory agencies. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Works with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups, Information Technology, and other departments as needed.
May submit submissions for changes to labeling, QC, manufacturing, or distribution practices. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Department procedures, as needed.
- Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guidelines.
- Prepare paper based and electronic submissions, including both eCTD and non eCTD formats, for multiple project to regulatory agencies, and ensure the timely delivery of quality submissions.
- Critically review submission documentation and provide input to respective departments for necessary revisions.
- Coordinate and prepare responses to FDA Deficiency Letters and other agency requests.
- Using eCTDXpress complete submission publishing for submission through ESG
BS or MS in scientific discipline or equivalent education and experience.
Minimum 3 years previous work experience in the pharmaceutical industry, preferably in the area of drug regulatory affairs, analytical, QA, R&D or production experience.
Must have a working knowledge of US Regulatory Submissions
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.