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Mgr Regulatory Affairs - 1433

Date: May 9, 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!

Job Description

The Regulatory Affairs Manager is responsible for the supervision, preparation, and critical review for Teva’s Must Win and sterile / complex products to ensure that high quality (RFT) supplements are filed to the Agency (including PASs, CBE0/30s, ARs, Post Amendments, other supplements as needed).  The Manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The incumbent, with minimal guidance, evaluates changes and signs-off on change control documents for Teva’s Must Win and sterile / complex products, ensuring the correct filing category.  He/she 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.   

 

The incumbent will attend calls with sites supporting the US market and will work closely with the Regulatory Affairs Director/Senior Director to prioritize the review of change controls, annual reports and supplements compiled by the Regulatory Affairs team in India to ensure the regulatory strategy has been properly executed.

 

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 Manager will be help to take the lead on intra/inter departmental/cross-functional initiatives and continuous improvement initiatives.

  • Manage the regulatory associates in the preparation, compilation and submission of high quality:  supplements, annual reports, control documents, etc. to FDA authorities.
  • Critically review change controls, annual reports and supplements compiled by the Regulatory Affairs post approval team. Work closely with all departments at site to obtain the required documentation for upcoming post approval submissions
  • Manages quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Coaches, mentors and provides guidance to the regulatory associates. 
  • Evaluates changes to regulatory documents for Teva’s Must Win and complex products and formulate strategies for correct filing categories, with guidance from supervisor.
  • Acts as main representative for Regulatory Affairs on cross functional project teams. 
  • Interacts with FDA and all of the company sites via written and phone communications.
  • Other duties, as assigned, or as business needs require.

Qualifications

  • PharmD/BS degree in a scientific discipline.
  • Minimum 8 years pharmaceutical industry experience:  5+ years Regulatory Affairs required coupled with 2 years Analytical, QA, laboratory, or production experience preferred.
  • Previous Managerial experience preferred
  • Exhibits strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs.
  • Demonstrates a basic understanding of pharmaceutical drug development. 
  • Ability to manage timelines within a project team environment.
  • Ability to work independently and on teams.
  • Ability to effectively liaise with FDA, various disciplines within Teva, and third parties. 
  • Ability to establish and maintain good working relationships.
  • Demonstrates good negotiation and management skills.
  • Excellent verbal and written communication skills.  
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sr. Director, Regulatory Affairs - 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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