Junior Serialization & Laboratory Software Platforms Administrator
Demo S.A.
Full time
Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C
Demo S.A.· Regulatory Affairs
About this role
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.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C position at Demo S.A.?
The salary for this Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C role at Demo S.A. is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C position at Demo S.A. located?
This Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C role at Demo S.A. is based in Hyderabad, Telangana, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C role in the Regulatory Affairs department at Demo S.A..
Which team or department does the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C at Demo S.A. belong to?
This Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C position is part of the Regulatory Affairs department at Demo S.A.. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C position at Demo S.A.?
Click the "Apply Now" button on this page. You will be redirected to Demo S.A.'s official application portal hosted on workable where you can submit your application directly.
When was the Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C job at Demo S.A. posted?
This Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C position at Demo S.A. was posted on May 27, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Senior Associate - Product Labelling - DEMO Global Services C
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.