Manager Regulatory Affairs
: Job Details :

Parsippany, United States, New Jersey, 07054

Job Id: 57668

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

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 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 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.

• 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 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, MAPPs, PSG, and information sites, such as DECRS, Orange Book, IID Database, DMF Available for Reference, FDA Inspections Dashboard and ICH guidance.
• Knowledge of USP Pharmacopeia.
• Mentoring and training colleagues.
• Electronic documents management systems.
• Electronic common technical documents (eCTD) per FDA and ICH guidance and FDA's NextGen Portal; and MS Word, MS Power Point, MS Excel and Adobe Acrobat.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.