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

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.