The opportunity
Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile documentation and data necessary for the following: submissions of assigned ANDAs, responses to FDA Deficiency letters, Correspondences and post approval supplements to ensure compliance with applicable regulations and guidance’s with limited supervision from manager. Assess change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determination. Review applicable revised and new regulations and guidance’s distributed by FDA. Train on internal SOPs (Standard Operating Procedure) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D projects to R&D, and applicable project stakeholders, to ensure alignment on Agency requirements. Local telecommuting permitted up to 2 days per week.
Your experience and qualifications
Requires a Bachelor’s degree in Pharmacy, Drug Regulatory Affairs or a related field, and 3 years of Regulatory experience.
Must have experience with:
Working on New Drug Applications (NDA’s) and Abbreviated New Drug Applications (ANDA’s) and associated amendments, for various dosage forms (solutions, solid oral, semi-solid, or combination products).
Authoring, reviewing and compiling documents required for Modules, 1, 2, 3 and 5.
Authoring, reviewing and compiling the following types of submissions, general and controlled correspondences.
Authoring, reviewing and compiling complex post-approval submissions (manufacturing, testing and packaging site transfers for immediate and extended/modified/delayed release products, addition of alternate drug substance suppliers, changes to formulation, changes to manufacturing process, supplements to address DMF amendments, changes to in-process, release, stability controls, and changes to analytical testing methods, changes to container closure systems).
Authoring, reviewing and compiling Annual Reports, CBE-0, CBE-30, Prior Approval Supplements, Correspondences, responses to deficiencies related to facilities, Administrative Changes, and Transfer of Ownership Letters.
Corresponding via email and submissions with the FDA regarding extension requests, follow-up on granting/approval/discipline review status, clarification questions, and meeting requests.
Representing Regulatory Affairs in inter and intra-departmental meetings.
Working with third party contract manufacturing, packaging and testing sites.
Assessing Change Controls for Chemistry, Manufacturing and Controls (CMC); Knowledge of USFDA regulatory guidance’s, MAPPs, PSG, and information sites, such as DECRS, Orange Book, IID Database, DMF Available for Reference, FDA Inspections Dashboard and ICH guidance’s.
Knowledge of USP Pharmacopeia.
Mentoring and training colleagues.
Electronic documents managements systems.
Electronic common technical documents (eCTD) per FDA and ICH guidance’s and FDA’s NextGen Portal; and MS word, MS Power Point, MS Excel and Adobe Acrobat.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
Apply at https://www.tevapharm.com/your-career/; reference Req. 57668.
