Regulatory Affairs Associate II – 1435
Date: Mar 24, 2023
Location:
Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 46824
Who are we?
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!
Regulatory Affairs Associate II – RIMS
Primary Purpose of the Role
The primary purpose of this position is to execute the operations and services applicable to the GRO RIM role in line with business goals and objectives.
Main Duties & Responsibilities
Responsible for executing GRO RIM operations in line with Work Instructions and SOPs. Primarily will be RIM Central Data Service related product registration data management (includes the procurement of data from source regulatory documentation which requires a thorough understanding of the structure and contents of a regulatory dossier, and a thorough understanding of the data structures applicable to registration data and the related system workflows).
Operationally hands-on in terms of carrying out data management activities as an individual contributor. This will require a thorough understanding of the structure and contents of a regulatory dossier (i.e. will be fluent in navigating and understanding the contents of a dossier). Registration data management will require a thorough understanding of the registration data structures, workflows, and applicable work instructions etc.
Perform Quality Control (QC) and data integrity checking, as part of the RIM Central Data Services operation, to confirm the accuracy and completeness of the Teva Global Registration database.
Represent GRO RIM across the wider Global Regulatory Affairs community. Must be proficient at building effective working relationships with all stakeholder and customer groups.
Qualifications
Minimum Educational Qualifications :
Required: Bachelor’s Degree in Life Sciences or Information Technology.
Preferred: MS in scientific or information technology discipline.
Minimum Years of Work Experience:
Required: 2-5 years
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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
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.
EOE including disability/veteran
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