At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Labeling Manager to join our team.
Management of pharmaceutical drug product labeling across global market (including Europe, TGA, Health Canada, APAC, GCC, CIS, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards. Managing the high-quality labeling, translation & artworks for drug packaging and inserts to ensure regulatory compliance. Updation and revision of labeling documents changes as per availability of new safety data and managing the post-approval variations.
Responsibilities:
- Managing the preparation of high-quality core labeling documents (SmPC package insert, safety labeling changes, structured product labeling, commercial labeling to ensure compliance against current guidelines and standards.
- Review of labeling documents to ensure regulatory labeling compliance with regulatory standards of Europe and global markets.
- Implement updates based on QRD templates, safety variations, and periodic safety update changes (PSUR, RMP updates).
- Ensure labeling conforms to EMA, CMDh, and national competent authority requirements.
- Localize labeling based on country‑specific requirements (e.g., Europe, Canada, Asia-Pacific, CIS, MENA/GCC, and various emerging regions).
- Managing translation and coordinate with translation agencies and internal teams to translate labeling content into required EU & global regional languages and ensure all translations are accurate and comply with regulatory standards.
- Managing the creation of final artwork for packaging, ensuring it is consistent with the approved labeling text and complies with required EU & global regional regulations regarding layout, font, and safety information and electronic formats (e.g., SPL, XML) for global submissions.
- Responsible for update and maintenance of product information.
- Timely submission of labeling documents and artwork to regulatory authorities as part of marketing authorization applications, safety variations, and renewals.
- Initiate and approve change controls for new and revised labeling including updating the labels for post-approval changes, such as new safety data, and manage the lifecycle of labeling documents.
- Collaboration with other departments, including marketing, medical, and operations, to ensure labeling and artwork are aligned with global and regional strategies.
- Monitor evolving regulatory requirements and provide proactive advice to cross-functional teams.
- Maintenance of labeling databases.
Requirements
- 10-12 years in regulatory affairs/labeling, with a significant portion (e.g., 6+ years) dedicated specifically to labeling regulatory affairs.
- Sound knowledge of national and EU pharmaceutical legislation & guidelines for labeling, and procedures (DCP, MRP, National), Australia, NZ, Canada and rest of world markets (CIS, MENA, ASEAN etc.)
- Demonstrated experience with the development, review, and maintenance of EU labeling documents is essential, including the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and packaging text.
- Attention to detail, excellent 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.
