Role Purpose
The Artwork, SPC & PIL Specialist is a technically demanding regulatory role responsible for designing, preparing, and maintaining pharmaceutical packaging artwork, product information documents (SPC and PIL), labeling, and pharmacovigilance communication materials — all in full compliance with SFDA requirements and international regulatory standards.
This role sits at the intersection of regulatory science, creative execution, and cross-functional coordination. The Specialist ensures that every piece of product-facing content — from carton artwork to patient leaflets — is accurate, compliant, and available to support submissions, manufacturing, and commercial supply without disruption.
Key Responsibilities1. Artwork Management
- Design and prepare pharmaceutical packaging artwork across all formats: cartons, labels, blister foils, sachets, bottle labels, ampoules, vials, and secondary packaging.
- Ensure all artwork fully complies with SFDA Artwork and Labelling Guidelines and internal company standards.
- Review, update, and maintain artwork in response to regulatory variations, safety updates, manufacturing changes, or supplier changes.
- Coordinate artwork development, review cycles, and approval with internal stakeholders and external manufacturers / CMOs.
- Maintain rigorous artwork version control and ensure proper archival of all approved artwork files.
- Review and approve printer proofs and packaging mock-ups before release to commercial production.
2. SPC, PIL & Labelling
- Prepare, format, review, and maintain Summaries of Product Characteristics (SPC), Patient Information Leaflets (PIL), and product labels.
- Ensure consistency and alignment between SPC, PIL, labels, and packaging artwork across the product portfolio.
- Incorporate SFDA comments, post-approval regulatory updates, and pharmacovigilance safety information into approved documents.
- Prepare compliant artwork and labeling documentation to support regulatory submissions and variation dossiers.
3. Pharmacovigilance Materials
- Design and maintain SFDA-compliant pharmacovigilance documents and communication materials, including:
◦ Adverse Event Reporting Forms
◦ Product Complaint Forms
◦ Educational and Risk Minimization Materials
◦ Safety Communication Materials
- Ensure all PV materials are current, compliant with SFDA Pharmacovigilance requirements, and aligned with company SOPs.
4. Supply Chain & Production Coordination
- Partner with Supply Chain and Procurement to ensure timely availability of approved artwork and labeling materials for production runs and product launches.
- Align artwork implementation timelines with packaging material procurement and manufacturing schedules to prevent supply disruptions.
- Provide finalized artwork files to relevant teams within agreed timelines; manage version handovers clearly.
- Coordinate with external printing vendors to ensure packaging materials are produced to approved specifications and quality standards.
5. Regulatory Compliance & Documentation
- Monitor SFDA regulatory updates related to artwork, labeling, SPC, PIL, and pharmacovigilance materials; proactively assess and implement required changes.
- Maintain complete documentation, version histories, and change control records — ensuring inspection-readiness at all times.
- Participate in internal audits and SFDA regulatory inspections as a subject-matter expert.
6. Cross-Functional Collaboration
- Work closely with Regulatory Affairs, Pharmacovigilance, Quality Assurance, Supply Chain, Procurement, Manufacturing, Medical Affairs, and external CMOs.
- Provide technical expertise on artwork, labeling, and packaging compliance to cross-functional teams and project stakeholders.
- Support new product registrations, lifecycle management activities, and post-approval regulatory variations.
- Actively contribute to product launch planning and packaging readiness workstreams.
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
