16 days old

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!

 

Tevas 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

  Teva is adding a Manager of Regulatory Affairs to their Parsippany, NJ  team. This role will be responsible for successfully strategizing and filing original Abbreviated New Drug Application submissions and for managing post approval changes and application compliance requiring regulatory submissions.  Moreover, they will act as the primary contact with all stakeholders for assigned projects and products and determine the nature and scope of information to be generated to successfully file required regulatory documents.  They will ensure that the company is informed of significant regulatory issues that affect assigned products/projects. 

 


Essential Duties & Responsibilities
    Carry out managerial responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.

    Direct, coordinate and prioritize the strategic activities of Regulatory Affairs. 

    Review and approve regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidances. 
FDA and ICH guidance. 

    Assess impact of new regulations and suggests appropriate changes to business processes/policies as necessary. 5%  

    Interact with various departments, both internal and external as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees. 

    Interact with the FDA to facilitate the timely approval of the regulatory submissions and obtain guidance on Regulatory issues. 

    Maintain awareness of all regulatory activities on assigned projects.  Schedules and tracks project specific and operational activities related to the Regulatory department. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.

    Interact with outside consultants and/or contractors as needed. 

    Train or participate in training subordinates in the preparation of documentation for regulatory review in technical areas and in current Good Manufacturing Practices (cGMP). 

    Provide support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.  
 

Qualifications


Education Required
Bachelors of Science Degree from an accredited college or university

Education Preferred 
MS or other advanced degree 

Experience Required
5+ years related regulatory experience in a pharmaceutical company


Experience Preferred
Development of both complex and non-complex generics across a multitude of dosage forms including combination products


Specialized or Technical Knowledge Licenses, Certifications needed:
FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.
Pertinent Federal and State laws related to pharmaceutical regulatory affairs.
Supervision and training practices and methods.
Business, scientific and personal computer software applications.
Business English usage such as, spelling, grammar and punctuation.
Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
Company policies, practices and procedures, including safety rules and regulations.
Principles and practices of budget preparation and administration

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 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: 2021-04-23 Expires: 2021-05-23

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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