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Watson Pharama
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Regulatory Affairs Associate I

Regulatory Affairs Associate I

Watson Pharama

1 - 9 years

6 - 7 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

sap regulatory affairs associate pharma project management packaging ms office regulatory affairs monitoring ariba recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Support EU Generics Labeling Managers and Labeling Germany Managers in providing pharmaceutically and medically accurate product labelling, especially for multiple regulatory procedures of one INN.
Manage translations for Centralized Procedures (CPs).

How you ll spend your day

Editorial Tasks

Perform various editorial tasks.
Review of SmPC and PIL as well as packaging materials using a review protocol.
Adapt texts to the current QRD template.
Proofread texts.
Prompt provision of product information and comments in regulatory database (GRIDS).
Responsibilities under the role of super-editor (GRIDS).
Coordinate and handle inquiries from other departments, locations, and service providers.

Screening for innovations in the EU regulatory environment

Monitoring of the literature (guidelines, best-practices) in the regulatory affairs environment for innovations, especially in the area of central approvals.

Translation Management for EU Centralized Procedures

Planning of all process steps after receiving the translation request.
Coordinate translations of English product information into the languages of EU member states, including Norway and Iceland, for CPs.
Internal QC check: coordination of communication between all stakeholders (local Markets, translation agency).
Coordinate linguistic reviews.
Evaluate translation tables from translation agency and/or local markets.
Providing necessary documents for submission (e. g. WORD annotated, PDF clean, translation tables).

SAP

Cost Center Administrator (release of invoices, accounting).

ARIBA

Management of purchase requisitions within the framework of service contracts (e. g. translations).

6. Work in a team environment.

Perform all other job-related duties as required by management and dictated by process changes.

Your experience and qualifications

Experience:
Experience in Regulatory Affairs or basic knowledge of European pharmaceutical law and the regulatory affairs environment.
Qualification:
Completed training as a pharmaceutical-technical assistant or medical assistant.
Other:
Intermediate to advanced English skills (spoken and written), excellent MS Office skills, basic knowledge of European pharmaceutical law and regulatory affairs, project management experience.

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