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Assoc. Director - Regulatory Affairs (Steriles) - Parsippany NJ

Date: May 8, 2019

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!

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.

Job Description

The Associate Director Regulatory Affairs is responsible for establishing, managing, and leading a highly productive (efficient/effective) team. He/she will work closely across a portfolio of sterile products for both pre-approval and post-approval activities. The incumbent will help to prepare/critically review regulatory submissions for Teva’s Must Win and complex products to ensure that high quality (RFT) submissions are filed to the Agency (including New Original ANDAs, Amendments, PASs, CBE0/30s, ARs, Post Amendments, other supplements as needed).

The Associate Director will evaluate regulatory issues and develop an accurate and timely regulatory strategy and alternatives, as needed, to the Management.  

The incumbent will review submissions and spot check change control requests and annual reports that are compiled by the team members to ensure the regulatory strategy has been properly executed.

The Associate Director Regulatory Affairs will attend calls with sites/regions supporting the US market and prioritize the workload for the team based on company requirements. 

Additionally, the incumbent will review new and revised FDA guidances and provide training to all colleagues affected by the guidances.  He/she will represent Regulatory Affairs on project teams and serve as a team leader for projects. 

The Associate Director will also support business development initiatives as required.

 In addition, he/she will accurately populate and maintain the databases and trackers in real time, as/if needed (change control tracker/Global Trackwise (GTW), annual report spreadsheet maintenance and Workload Tracker). 

The Associate Director will help to take the lead on intra/inter departmental/cross-functional initiatives

Qualifications

Education Required:

BS degree in scientific or healthcare discipline

Education Preferred

R.Ph., Pharm.D., M.S., or Ph.D. preferred

Experience Required:

10+ years in pharmaceutical industry experience with  8+ years in regulatory affairs with emphasis on CMC     

Experience Preferred:

6+ years in a supervisory position of leading a team, managing/coaching employees resulting in a highly productive and efficient team, training capabilities, and the ability to think outside of the box/creative approaches without risking submission quality. 

Strong knowledge of Sterile Products is a must.

Strong knowledge of Quality and Micro (for Sterile products) is a must.

Strong leadership skills and understanding of cross functional interactions needed by RA to compile comprehensive submission is a must.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sr Dir Regulatory Affairs, Gx Steriles

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

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