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Associate Director Regulatory Affairs

Date:  Jan 27, 2023
Location: 

West Chester, United States, 00000

Company:  Teva Pharmaceuticals
Job Id:  42267

Who are we?

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

General Description

The CMC Regulatory Affairs Associate Director manages the day-to-day regulatory activities for all assigned marketed products, as well as those products that are currently in development.  The responsibilities of the CMC Regulatory Affairs Associate Director include compiling, organizing, and assessing documents for regulatory submissions to health authorities (e.g., FDA, Health Canada) as well as coordinating with global regulatory colleagues in preparing dossiers for products for global registration.

The CMC Regulatory Affairs Associate Director is responsible for identifying and evaluating CMC issues associated with development products including product and process development, analytical methods, formulation development, manufacturing,  and labeling.  The CMC Regulatory Affairs Associate Director is also responsible for maintaining and updating CMC sections of submissions for Teva products.  The CMC Regulatory Affairs Associate Director will interface with development and manufacturing groups, as well as with internal regulatory departments. The CMC Regulatory Affairs Associate Director will lead cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with FDA. 

Major Duties and Responsibilities 

⦁    Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidances and directives, and evaluating and communicating their applicability to the development teams.
 
⦁    Develop and communicate effective CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development. 

⦁    Collaborates with the Cross Functional Digital Health, Commercial, Quality, Combination Product development teams through progression of internal developmental programs.   

⦁    Coordinate, author and review the CMC sections of IND, NDA and CTA filings.  Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.

⦁    Support the global registration initiative for marketed products by liaising with Regulatory counterparts in the Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.

⦁    Lead the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications, protocols and reports.

⦁    Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.

⦁    Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.  

Qualifications

Minimum Knowledge and Skills Required

⦁    Bachelor’s degree in scientific discipline. 
⦁    At least  8 years of pharmaceutical industry experience. 

Knowledge and Skills Preferred

⦁    Advanced degree ( M.Sci., Ph.D., PharmD) is preferred.
⦁    5 years of Regulatory Affairs experience preferred
⦁    Relevant technical experience in Combination Products, Digital Health Products, Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.
⦁    Knowledge of FDA and ICH Regulatory guidelines
⦁    Experience with eCTD regulatory filings
⦁    Knowledge of U.S. and global content and regional requirements
⦁    Knowledgeable in drug development processes and life cycle management of products 
⦁    Clear, concise technical writing skills 
⦁    Ability to manage multiple projects and competing timelines 
⦁    Ability to assess regulatory requirements and filing timelines in order to judge the work required for submission of a quality filing 
⦁    Ability to assess technical quality of documents and to provide regulatory feedback to colleagues 
⦁    Ability to respond quickly with reasonable solutions and alternatives to regulatory-related problems
⦁    Good interpersonal, communication and organizational skills.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director/Sr. Director

Already Working @TEVA?

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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.

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations