Job Description

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?

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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.

Teva Pharmaceuticals