The opportunity
Teva Pharmaceuticals USA, Inc. is seeking multiple Managers, Regulatory Affairs (Parsippany, NJ) to evaluate change controls, provide regulatory assessment within the company system to regulatory documents, and formulate strategies with minimal guidance, to ensure proper filing categories. Compile and review high quality submissions (Abbreviated New Drug Applications/New Drug Applications, amendments, supplements, annual reports, etc.). Draft ANDA/NDA modules for original applications, amendments, supplements, etc., for FDA submission. Draft deficiency letter responses and coordinate cross functionally (internally and externally) to obtain accurate documentation. Lead Right First Time Submissions (including ANDAs/NDAs, amendments, supplements, etc.). Maintain full awareness of all regulatory activities on assigned projects and ensure that the project deadlines and performance standards for these projects are established and met. Work with internal and external stakeholders to manage submission schedules. Update tracking sheets as needed. Contribute to the preparation of meeting packages related to pre and post ANDA/NDA meetings with FDA. Assess and remain current with new and changing guidances/regulation. Train, or mentor, team members and/or new employees. Local telecommuting permitted up to 2 days per week.
Your experience and qualifications
Requires a Bachelor’s degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience.
Must have 2 years of sterile/ parenteral dosage form experience (such as different forms of injections, ophthalmics, or otics).
Must have experience with:
Chemistry, Manufacturing and Controls (CMC) in drug development process.
Quality Target Product Profile and Critical Quality Attributes, drug composition, product and process design, various specification settings, analytical methods, analytical method validation, sterility assurance, manufacturing, stability design and stability data analysis during drug development and life cycle of drugs.
Change controls and regulatory assessment of change controls.
Software to assess change controls such as TrackWise;
FDA/ICH regulations pertaining to Generic Drug User Fee Act (GDUFA)/ Prescription User Fee ACT (PDUFA), CMC and regulatory filing aspects; Drafting correspondences to FDA.
Software (such as Liquent/ Docubridge/ eCTD Express) used in Regulatory Operations; and MS Word, MS Excel, Adobe Pro and using internet to browse FDA websites and other FDA information repositories (IIG database, Orange Book, Drug Approval Database, Dailymed, Product Specific Guidance database).
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
Apply at https://www.tevapharm.com/your-career/; reference Req. 56073.
