Teva Pharmaceuticals Regulatory Affairs Associate II in Parsippany, New Jersey
Regulatory Affairs Associate II
Date: May 22, 2020
Location: Parsippany, New Jersey, US, 07054
Company: Teva Pharmaceuticals
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com
Position Summary: The Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports and additional documents (for sterile products) as needed. Compiles and reviews ANDAs, amendments, supplements, annual reports, control documents, etc., for FDA submissions. Interacts effectively with functional business units in order to coordinate facilitate documentation required for submissions, ensuring that departmental timelines are met.
Essential Duties & Responsibilities
Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
Interacts with FDA and all Teva sites via written and phone communications.
Preparing Right First Time ANDAs and amendments for FDA submission.
Evaluating change controls and provide the regulatory assessment.
Performing special projects assigned by Regulatory Affairs management.
Other duties, as assigned, or as business needs require.
Timely submissions and expeditious approvals.
Maintains compliance with regulatory requirements for generic drugs for the US market.
Coaches and mentors other associates. Trains less senior associates to review change requests and provides guidance to other associates in the preparation of other FDA submissions.
BS in a scientific discipline or equivalent education and related experience
Minimum four years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory, or production experience preferred.
Basic computer skills such as Word, Excel and familiarity with the internet
Ability to manage timelines with a project team environment
Ability to work independently and on teams
Good verbal and written communication skills
Mustbe well organized, detail oriented, have the ability to multi-task and manage changing priorities
Medical Regulatory Affairs
In process of validation
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Teva’s Equal Employment Opportunity Commitment
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.
EOE including disability/veteran