1+ months

Manager Regulatory Affairs

Parsippany, NJ 07054

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. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

Impact:
Around 200 million people worldwide take one of our medicines every day. In the United States, where Teva is the leading generic pharmaceutical company, one out of every nine prescriptions is filled by a Teva product. In the both the UK and Canada, it is one out of every six.  In addition, many prescription medications made by other companies include active pharmaceutical ingredients produced by Teva.

 

As the Manager, Regulatory Submissions Management  you will be reporting to the Dir NA Reg Submissions Mgmt, NA Regulatory Ops - US, is responsible for coordinating, publishing and dispatch of major and complex lifecycle management eCTD submissions such as INDs, ANDA, NDAs, sNDA, BLA as well as providing electronic publishing support as needed. 

 

YYou will  serve as a first-line manager with 2+ direct reports and be responsible for managing the daily activities and workload of a site publishing team. Performance management activities include goal-setting and development plans, as well as ensuring that individuals are trained and comply with all SOPs and internal publishing standards. 

In addition, this role is responsible for coordinating the planning and tracking of submission activities with the Regulatory Affairs personnel and will be a key member of Global Regulatory Affairs project teams.

 

  • Manage daily activities and workload of site publishing team ensuring that individuals are trained and comply with all SOPs and internal publishing standards
  • Coordinate and lead major and complex routine/lifecycle management eCTD submission projects.
  • Publishes regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems
  • Act as system Subject Matter Expert for publishing tools and standards
  • Prepare and deliver performance management and career development plans for staff
  • Participate in Global Regulatory Operations management team meetings
  • Participate in Global Regulatory Affairs project teams
  • Working knowledge of EDMS (Veeva Vault preferred), and authoring tools
  • Strong time management and organizational skills required and having robust problem-solving skills in relation to streamlining department processes

Qualifications:

Education Required: Bachelors Degree in Life Sciences or Information Technology

Education Preferred:  MS in scientific or information technology discipline
 

Experience Required: 5 plus  years in Regulatory Operations/Regulatory Affairs                      
Experience Preferred: Experience in managing a Regulatory Operations team

 

Technical Knowledge:

  • Experience with Liquent InSight suite, Microsoft Office suite, Adobe, Documentum, and eCTD technology
  • Basic understanding of IT infrastructure
  • Understanding of the drug development process.  Knowledge of generics and branded product development a plus
  • Working knowledge of industry legislation and best practices
  • Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)

 

 

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: 2021-03-17 Expires: 2021-06-12

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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Manager Regulatory Affairs

Teva Pharmaceuticals
Parsippany, NJ 07054

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