Regulatory Affairs Associate II

2 - 5 years

6 - 7 Lacs

Posted:3 hours ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Affairs Associate II Job Details | Teva Pharmaceuticals

We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies.

Modify Cookie Preferences
Accept All Cookies
Find a Career With Purpose at Teva
Search by Postal Code
Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate II Navi Mumbai, India, 400706
Who we are
The opportunity

The role of GRO Regulatory Data Analytics is to:

  • Manage Teva s data in accordance with requirements for xEVMPD in order to maintain Teva s Article 57 compliance.
  • Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs.
  • Provide SME services for data management processes and execution in current and future regulatory data systems

The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives.

How you ll spend your day
  • Responsible for executing GRO Regulatory Data Analytics operations in line with Work Instructions and SOPs. Primarily will be Regulatory Data Analytics Service related to 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 GRO Regulatory Data Analytics operation, to confirm the accuracy and completeness of the Teva Global Registration database.
  • Represent GRO Regulatory Data Analytics across the wider Global Regulatory Affairs community. Must be proficient at building effective working relationships with all stakeholder and customer groups.
  • Responsible for providing effective business project contributions for projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data or the regulatory technology landscape.
  • Support the Manager as necessary in the execution of Regulatory Data Analytics activities. Will include assuming responsibility for various Regulatory Data Analytics data management process and oversight related tasks and activities.
  • Coach and develop individuals within the team in line with the changing needs of the organization and the capabilities of the individuals themselves.
  • Responsible for the operation of Regulatory Data Analytics processes including RIM data admin related data management activities.
  • Identify opportunities for process improvement and capable of implementing change effectively within a professional regulatory environment.
  • Support RIM in both industry and company driven initiatives which result in the change of data management practices and implementation of new processes
Your experience and qualifications

Minimum Educational Qualifications

Required: Bachelor s or Master 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 (Preferred experience in regulatory operations/affairs)

Teva s Equal Employment Opportunity Commitment

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

These cookies are required to use this website and cant be turned off.

Provider Description Enabled SAP as service provider
We use the following session cookies, which are all required to enable the website to function:
  • "route" is used for session stickiness
  • "careerSiteCompanyId" is used to send the request to the correct data center
  • "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor
  • "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Watson Pharama logo
Watson Pharama

Pharmaceuticals

Pharma City

RecommendedJobs for You