Job Summary

We are seeking a detail-oriented and organized qualified for the QA function with expertise in pharmaceutical regulatory documentation, product permissions, export certifications, and packaging artwork compliance.

The candidate will be responsible for coordinating regulatory approvals, managing product-related documentation, ensuring packaging artwork compliance with approved regulatory dossiers, and liaising with domestic and international clients, CDSCO, State FDA authorities, and internal departments.

The role will support legal market access, manufacturing approvals, and pharmaceutical exports by ensuring timely and accurate completion of applicable regulatory requirements.

Key Responsibilities

1. Regulatory Affairs & Product Approvals

- Coordinate and follow up on Product Permission applications, manufacturing approvals, and other applicable regulatory authorizations.
- Prepare, compile, review, and maintain regulatory documents required for product approvals and renewals.
- Coordinate applications for Certificates of Pharmaceutical Products (CoPP), No Objection Certificates (NOC), and other applicable export-related certificates.
- Liaise with CDSCO, State FDA authorities, and other relevant regulatory bodies for submissions, clarifications, queries, and approval status.
- Track regulatory timelines, pending applications, renewals, and approval commitments.

2. Pharmaceutical Artwork Preparation & Verification

- Coordinate with domestic and international clients to understand product packaging and labelling requirements.
- Review and verify artwork for cartons, labels, blister foils, package inserts, and other packaging components.
- Ensure that product names, strengths, composition, warnings, storage conditions, manufacturer details, and other required particulars match the approved product documents and applicable regulations.




- Maintain artwork version control and ensure that only the duly approved artwork is released for printing and use.
- Coordinate artwork revisions and approvals with QA, Regulatory Affairs, Production, Packaging, and client teams, as applicable.

3. Quality Assurance & Regulatory Compliance

- Ensure adherence to applicable pharmaceutical quality systems, approved procedures, and relevant regulatory requirements.
- Support compliance with applicable CDSCO, State FDA, and destination-country regulatory requirements, including US FDA requirements where relevant.
- Maintain accurate and traceable records of regulatory submissions, approvals, artwork revisions, and supporting documentation.
- Identify discrepancies in product documentation or packaging artwork and coordinate corrective actions with the concerned departments.
- Support internal audits, regulatory inspections, and documentation reviews related to the assigned responsibilities.

4. Client & Cross-Functional Coordination

- Act as a key coordination point for domestic and international clients on regulatory documentation and artwork-related matters.
- Communicate regulatory requirements and client specifications clearly to internal teams.
- Follow up on pending documents, approvals, regulatory queries, and client feedback.
- Coordinate with QA, Production, Packaging, Regulatory Affairs, and other relevant departments to ensure timely completion of assigned activities.

5. Documentation & Reporting

- Maintain regulatory trackers, approval registers, artwork logs, and document control records.
- Monitor application status, approval deadlines,



renewals, and pending regulatory actions.
- Prepare periodic status reports for management.
- Ensure proper filing, retrieval, traceability, and confidentiality of regulatory records.

Required Qualifications & Skills

- B.Sc., M.Sc., or B.Pharm in Pharmacy, Chemistry, Life Sciences, Biotechnology, or a related scientific field.
- Relevant experience in pharmaceutical QA, Regulatory Affairs, regulatory documentation, or packaging artwork coordination.
- Working knowledge of CDSCO and State FDA regulatory processes.
- Practical exposure to Product Permissions, CoPP, NOC, manufacturing approvals, or pharmaceutical export documentation is highly desirable.
- Understanding of pharmaceutical packaging, labelling requirements, artwork verification, and version control.
- Good written and verbal communication skills.
- Strong documentation, coordination, follow-up, and organizational skills.
- Proficiency in MS Office, particularly Excel, Word, and email communication.

Preferred Experience

- Experience in pharmaceutical manufacturing and export-oriented organizations.
- Exposure to domestic and international product registration requirements.
- Experience coordinating with regulatory authorities and international clients.
- Familiarity with quality management systems, document control, and regulatory audit requirements.

Key Performance Indicators (KPIs)

- Timely preparation and submission of regulatory applications.
- Accuracy and completeness of regulatory documentation.
- Effective tracking and follow-up of product permissions, CoPP, NOC, and other applicable approvals.
- Compliance of packaging artwork with approved documents.
- Timely closure of artwork revisions and regulatory queries.
- Maintenance of accurate, traceable, and audit-ready records.

Pay: Up to ₹300,000.00 per year

Work Location: In person

📌 Quality Assurance (QA) – Regulatory Affairs & Artwork Coordination (Ahmedabad)
🏢 Accretion Pharmaceuticals
📍 Ahmedabad