Regulatory Affairs Associate I

Role :

Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics)

Primary purpose of the role :

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.

Main Duties & responsibilities :

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.

Qualification & Experience :

B Pharm / M Pharm only

1-3 years (Preferred relevant experience in regulatory operations / affairs only)

Experience of the pharmaceutical industry with direct experience in Regulatory Affairs, possessing a solid understanding of the pharmaceutical regulatory affairs process.

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

Best regards

Ankita