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Regulatory Affairs Associate III - US FDA Pre approvals

Date: Nov 3, 2022

Location: Ambernath, IN, 421506

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!

Job Description

  • Perform all regulatory activities for assigned projects (original applications and deficiency responses), including review of CMC documents for submission, preparation of required eCTD documents, submission compilation, content plan preparation, coordination and collaboration with other business functions such as RA Labeling and Legal group and coordination with the publishing group and post publishing reviews and quality checks
  • Meet due dates assigned for original applications and deficiency letter responses
  • Work closely with management to initiate regulatory strategy on CMC issues throughout the drug development process with a right first time approach and during regulatory submissions and review cycles as well as supporting activities for product launch
  • Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in a timely manner
  • Critical review of CMC documents for submission to ensure high quality documents are prepared for product submissions meeting the US regulatory requirements
  • Responsible for evaluating change controls for regulatory filing assessments in accordance with FDA guidance documents
  • Keep current with the FDA Guidances/ICH regulations pertaining to GDUFA, CMC and regulatory filings
  • Identification of new trends and review practices experienced through deficiency letters and using it for regulatory strategy for future products
  • Ensures compliance with all company policies and procedures, including safety rules and regulations
  • Other projects and duties as required/assigned

 

Qualifications

Qualification :

Bachelor’s degree in a scientific discipline, preferably in life sciences. B.Pharm is a plus.

Master’s degree in a scientific discipline, preferably in life sciences. M.Pharm and/or MS in RA is a plus.

 Work Experience:           

8 to 10 years in the pharmaceutical industry in RA, R&D, Analytical RD or Quality with 6+ years in Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical

industry. Experience of regulatory submissions and deficiency responses to US FDA a distinct advantage.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

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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.