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Regulatory Affairs Associate I

Regulatory Affairs Associate I

Watson Pharama

1 - 3 years

3 - 5 Lacs

mumbai navi mumbai

Posted:9 hours ago| Platform:

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Skills Required

procurement regulatory affairs associate sap data management system integration data structures life sciences information management information technology recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

The role of GRO Regulatory Data Analytics is to:

Manage Teva s data in accordance with requirements for xEVPMD 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 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 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.

Your experience and qualifications

Minimum Educational Qualifications:

Required: Bachelors or Masters degree in Life Sciences or Information Technology.

Preferred: MS in a scientific or information technology discipline

Minimum Years of Work Experience:

Required: 1 3 years (preferably with experience in regulatory operations/affairs).

Job Knowledge and Skills

Required:

Interest in pharmaceutical regulatory affairs.

Aptitude for regulatory data management.

Preferred:

Experience in the pharmaceutical industry with direct involvement in regulatory affairs, demonstrating a strong understanding of the pharmaceutical regulatory process.

Experience in managing regulatory product registration data, ideally within a regulatory information management environment

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Regulatory Affairs Associate I