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Manager Regulatory Affairs

Date: Mar 25, 2021

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

 

 

R&D:
Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
 

Job Description

In your new role as Manager of Regulatory Affairs you will report to  the Associate Director  Gx RA, Steriles, Non-Steriles Gx RA - US, with minimal guidance and supervision prepares, reviews and submits high quality, right first time regulatory submissions (complex ANDAs, 505(b)(2)s, amendments, supplements, annual reports) to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.  In addition, reviews and provides assessments for control documents for FDA submissions. Interacts effectively with internal and external functional stakeholders in order to facilitate documentation required for submissions, ensuring that departmental timelines are met.

 

Travel Requirements:  Minimal

 

Essential Duties & Responsibilities:
 

  • Evaluating change controls and providing regulatory assessment within the company system to regulatory documents and formulate strategies with minimal guidance, to ensure proper filing categories.
  • Compilation and review of high quality submissions (ANDAs/NDAs, amendments, supplements, annual reports, etc.).
  • Drafting ANDA/NDA modules for original applications, amendments, supplements, etc., for FDA submission.
  • Drafting deficiency letter responses and coordinating cross functionally (internally and externally) to obtain accurate documentation
  • Leading Right First Time Submissions (including ANDAs/NDAs, amendments, supplements, etc.)
  • Maintaining full awareness of all regulatory activities on assigned projects and ensure that the project deadlines and performance standards for these projects are established and met.
  • Working with internal and external stakeholders to manage submission schedules
  • Updating tracking sheets as needed

Qualifications

Position Requirements:

 

  • BS in a scientific discipline or equivalent education and related experience. MS preferred. 
  • Minimum five years of Regulatory Affairs experience with two to three years of sterile experience.
  • Basic computer skills such as Word, Excel and familiarity with the internet
  • Ability to manage timelines with a project team environment
  • Ability to work independently and on teams
  • Good verbal and written communication skills
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities
  • Direct experience with assessments for change control documents for FDA submissions

 

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

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’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.

 

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. 

 

 


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Nearest Secondary Market: Newark