17 days old

Senior Manager Regulatory Affairs

Salt Lake City, UT 84111

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

Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated toensure comprehensive filings for FDA review (ANDAs, deficiency response amendments, TA to FA amendments, post-approval supplements). Keeps Company informed of significant regulatory issues that affect assigned products/projects.

 

Essential Duties & Responsibilities


    Carries out managerial responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
    Prepare, review and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance.
    Works effectively on interdisciplinary project teams.  Draws on expertise and experience to provide value, innovation, and guide direction in earlier stage research and development
    Effective at prioritization across many projects (5 15) including early stage research and development, filing phase, deficiency rounds, and post-approval.
    Assess risks throughout R&D, filing, deficiency rounds and post-approval and documents these risks appropriately
    Escalates project issues and risks to management appropriately
    Leads preparation meetings for FDA.  For example, leads in defining questions and all supporting information for Pre-ANDA meeting with FDA for complex projects.
    Leads deficiency response meetings: defining scope, deliverables, and response strategies
    Conveys a positive energy, motivating RA colleagues and interdisciplinary project teams.
    Build striong relationships with interdisciplinary project teams and RA colleagues.
    Interacts with various departments as needed on regulatory issues and/or strategy.
    Effectively guides, communicates and implements determined strategy with the
appropriate departments and/or employees.
    Reviews and approves change notices, specifications, batch records, standard test
methods, etc.
    Implements policies to assure on-going compliance of Regulatory Affairs activities.
    Assesses impact of new regulations and suggests appropriate changes to business
processes/policies as necessary.
    Proposes new efficiencies for Teva RA departments day to day practices
    Interacts with the FDA to facilitate approval of the regulatory submissions.
    Maintains awareness of all regulatory activities on assigned projects. Works to minimize
regulatory issues and helps prevent unnecessary regulatory delays.
    Meets project deadlines and established performance standards.
    Complies with all Company policies and procedures, including safety rules and
regulations, and guides subordinates in this area.
    Performs related duties as assigned.

 

*Relocation may be available

Qualifications

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

 

Education Preferred 
MS or other advanced degree 
 


Experience Required
10+ 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: 2021-04-21 Expires: 2021-06-06

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
Salt Lake City, UT 84111

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