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.

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.

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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Regulatory Affairs Senior Associate - Product Labelling

Job Description

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