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Regulatory Affairs Associate I
full-timeNavi Mumbai

Summary

Location

Navi Mumbai

Type

full-time

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About this role

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities.  The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

How you’ll spend your day

  • Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
  • Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
  • Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
  • Collaborate with scientific personnel for planning, preparation and publishing
  • Maintain working knowledge of internal and external publishing standards.
  • Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
  • Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Your experience and qualifications

  • B. Pharm/M. Pharm/ Master of Life Sciences.
  • Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
  • Command over spoken and written English
  • Sensitivity to the cultural diversity of a global organization
  • Good understanding of regulatory IT systems

Reports To

Manager – Regulatory Submission Management

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.

Other facts

Tech stack
Regulatory Affairs,ECTD,Publishing,Quality Control,Document Management,ICH Guidelines,Global Insight,Veeva Vault,Adobe Acrobat,Lorenz Validator,Collaboration,Life Sciences,English Proficiency,Cultural Sensitivity,Regulatory IT Systems

About Teva Pharmaceuticals

Teva Pharmaceuticals is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how we make it happen, visit www.tevapharm.com.

Our community guidelines may be found here: https://www.tevapharm.com/news-and-media/teva-social-media-guidelines/

Please note that adverse effects for any of our products should be reported at: https://www.tevapharm.com/teva-medical-information/report-a-side-effect-form/

Product-specific questions should be directed to Teva or Teva Group subsidiaries in your country. Contact details and Teva's Pharmacovigilance Privacy Policy may be found here:
http://www.tevapharm.com/contact_us/

Team size: 10,001+ employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing

What you'll do

  • The Regulatory Affairs Associate I will participate in the publishing of various regulatory activities, focusing on ensuring quality and timelines for submissions. This role involves collaborating with scientific personnel and maintaining knowledge of publishing standards.

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Frequently Asked Questions

What does a Regulatory Affairs Associate I do at Teva Pharmaceuticals?

As a Regulatory Affairs Associate I at Teva Pharmaceuticals, you will: the Regulatory Affairs Associate I will participate in the publishing of various regulatory activities, focusing on ensuring quality and timelines for submissions. This role involves collaborating with scientific personnel and maintaining knowledge of publishing standards..

Why join Teva Pharmaceuticals as a Regulatory Affairs Associate I?

Teva Pharmaceuticals is a leading Pharmaceutical Manufacturing company.

Is the Regulatory Affairs Associate I position at Teva Pharmaceuticals remote?

The Regulatory Affairs Associate I position at Teva Pharmaceuticals is based in Navi Mumbai, Maharashtra, India. Contact the company through Clera for specific work arrangement details.

How do I apply for the Regulatory Affairs Associate I position at Teva Pharmaceuticals?

You can apply for the Regulatory Affairs Associate I position at Teva Pharmaceuticals directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Teva Pharmaceuticals on their website.