Share this Job

Manager Regulatory Affairs - Sterile

Date: Jun 25, 2022

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

Company Info

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!

Job Description

Position Summary:  

The manager is responsible for the supervision, preparation, and critical review of high quality regulatory submissions to the FDA including:  ANDAs, NDAs, amendments, supplements and meeting requests.  The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager represents Regulatory Affairs on project teams and serves as team leader for projects. The Manager will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets/KPIs are met while adhering to appropriate statues, regulations and guidances. In addition, he/she will accurately populate and maintain the databases and trackers in real time (change control tracker/Global Trackwise (GTW), Workload Tracker and Global Insight).  Manager will be help to take the lead on intra/inter departmental/cross-functional initiatives.

Qualifications

Required: BS in Scientific discipline

Required: min 8 yrs pharmaceutical industry experience, min 5 years regulatory affairs experience, min 2 years analytical/QC,R&D/laboratory or production experience

Required: For Sterile Position - previous injectable/sterile product experience

Preferred: Pharm D

Preferred : Previous approval experience with 505(b)2 and 505(j) 

Preferred: RAC Certification

 

 

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Senior Manager/Associate Director/Director, RA

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.


Nearest Major Market: New York City
Nearest Secondary Market: Newark