Loading...
Share this Job

Manager, Regulatory Affairs

Date: Aug 27, 2021

Location: Weston, Florida, US, 33331

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!
 
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

 

 

Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing changes requiring regulatory submissions.  Secondary contact with regulatory authorities for assigned projects and products.  Determines nature and scope of information to be generated to ensure 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.  Works independently as a professional and keeps management informed of significant regulatory issues that affect assigned products/projects.

 

  • Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws, including safety rules and regulations.
  • 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.
  • 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
  • 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.
  • Escalates project issues and risks to management appropriately
  • Leads deficiency response meetings: defining scope, deliverables, and response strategies
  • 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.
  • Prepares content plans and coordinates publishing activities with the regulatory operations group
  • Proposes new efficiencies for Teva RA department’s day to day practices
  • Interacts with the FDA, as needed, to facilitate approval of the regulatory submissions.
  • Coordinates and prioritizes the daily activities of direct report(s), if assigned
  • Onboarding and coaching of new hires
  • Conducts performance evaluation for direct reports.

Qualifications

 

 

Education Required

  • Minimum of a Bachelors of Science Degree from an accredited College or University

 

Education Preferred

  • MS or other advanced degree

 

Experience Required

  • Minimum 6 years related regulatory experience with a pharmaceutical company

 

Experience Preferred

  • Development of both complex and non-complex generics for solid oral 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.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sr Director Regulatory Affairs

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.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami