16 days old

Senior Manager Regulatory Affairs

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

As the Senior Manager CMC, Regulatory Affairs (Specialty Products - Biologics) you will be responsible for developing, coordinating, and supporting the CMC aspects of regulatory submissions to global Health Authorities for new specialty products and marketed product registrations as well as licensing opportunities.  You may also be required to serve as the global regulatory project leader (GRPL).

 

You will lead and implement regional and/or global CMC strategy & submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs/ BLAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products. In addition, you will arrange for, coordinate and lead the team in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA).

 

Able to travel domestically (10%) and internationally (5%) when needed.

 

Other duties and responsibilities: 

  • Anticipates and understands the needs of internal and external customers.
  • Able to identify current key issues and anticipate key future issues and take them in consideration in the planning and management of projects.  Able to challenge the status quo to achieve continuous improvement.
  • Able to influence through communication based on logic and reason and to respond constructively to the needs of others. Able to negotiate effectively.  
  • Demonstrates the ability to evaluate critical data in order to identify the cause of a problem, seek appropriate expertise, and resolve or facilitate resolution.  Thinks through consequences of different courses of action.  
  • Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines
  • Knowledge of pharmaceutical drug development process
  • Proficient in project management. Demonstrates and encourages collective responsibility in teams. 

Qualifications

What you will bring to the role:

  • Bachelors degree in scientific field of study such as Biochemistry, Biotechnology, Cell Biology or equivalent
  • Minimum 7 years of pharmaceutical industry experience in new drug related product strategy and submissions 


Preferred Qualifications:

  • Masters degree or PhD, PharmD
  • Minimum 8 years of experience in regulatory affairs with proven experience in successful filing and defense of major submissionIND/NDA/BLA/CTA/MAA
  • Strong background in pharmaceutical development with focus on CMC aspects
  • Experience in implementing principles embodied in ICH Guidances Q8, 9, 10 including ObD

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director, Regulatory Affairs CMC

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 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.  

Categories

Posted: 2021-03-25 Expires: 2021-05-09

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Manager Regulatory Affairs

Teva Pharmaceuticals

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