# Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C

**Company:** [Demo S.A.](http://jobs.workable.com/companies/bfFZ3SuxMR5zjdkBWmB1yU.md)
**Location:** Hyderabad, India
**Workplace:** on site
**Employment type:** Full-time
**Department:** Regulatory Affairs

[Apply for this job](http://jobs.workable.com/view/671c1414-0026-485b-ac20-c0d03540115f)

## Description

At Demo SA, one of EU’s largest pharmaceutical manufacturers for injectable products, we are looking for a talented **Regulatory Affairs Senior Associate** - **Labeling** to join our team. The job responsibilities for this position include post-marketing regulatory submissions across global markets (including EU, Canada, GCC, APAC, LATAM and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards. **This position is based at Hyderabad, India.**

**Responsibilities:**

-   Prepare, review, and maintain product labeling content including SmPC, PI, PIL, IFU, artwork, cartons, and labels.
-   Ensure labeling aligns fully with regional regulations, product registration dossiers and approved claims.
-   Coordinate creation and updates of labeling components with cross‑functional teams
-   Implement updates based on QRD templates, safety variations, and periodic safety update changes (PSUR, RMP updates).
-   Ensure compliance with company style guides, branding standards, and internal labeling procedures.
-   Ensure labeling conforms to EU and national competent authority requirements.
-   Localize labeling based on country‑specific requirements (e.g., Asia-Pacific, CIS, MENA and various emerging regions).
-   Support eCTD Module 1 labeling content preparation.
-   Update and maintenance of product information.
-   Safety Variation filing and tracking
-   Manage multilingual labeling where required.
-   Coordinating with artworks preparations team for development of label / cartons / package insert for submission purposes.
-   Initiate and approve change controls for new and revised labeling.
-   Monitor global regulatory changes, guidance documents, and safety updates that impact product labeling.
-   Archive controlled label copies and master label files according to internal procedures.

## Requirements

-   Bachelor or Master Degree in Pharmacy with **6-10 years** of overall experience in labeling regulatory affairs.
-   Good understanding of Global Labeling Compliance as well as various operational activities in global labeling departments of regulatory affairs.
-   Strong organization skills, multi-tasking and able to meet deadlines.
-   Attention to detail, good time management, project management, presentation and communication skills (written or oral),
-   Good experience of IT tools often used in regulatory departments in the pharmaceutical industry.

## Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.