Role & responsibilities

Dossier & Documentation Management:

- Prepare, review, and maintain regulatory documentation, including Drug Master Files (DMFs), CEPs (Certificates of Suitability), and similar documents.
- Compile technical data packages, Safety Data Sheets (SDSs), and Certificates of Analysis (CoA) conforming to global standards.

Global Chemical & Pharma Compliance:

- Manage chemical registrations and compliance requirements and local environmental/safety mandates.
- Ensure compliance with current Good Manufacturing Practices (cGMP), ISO standards, and statutory laws governing chemical and intermediate production.

Customer & Supply Chain Support:

- Respond to technical and regulatory inquiries from global customers, providing detailed questionnaire packages, regulatory statements.
- Coordinate closely with R&D;, QC, QA, and Production teams to collate analytical data for new product launches or process changes.

Audit and Inspection Readiness:

- Assist in managing internal audits, regulatory inspections, and customer audits.
- Drive Corrective and Preventive Actions (CAPA)



arising from audits related to regulatory documentation and compliance gaps.

Regulatory Intelligence:

- Monitor changes in national and international regulations and assess their impact on company portfolios.

Preferred candidate profile

- B.Sc. or M.Sc Chemistry/Organic Chemistry.
- Experience required for Executive Post: 5-7 years of experience in Regulatory Affairs within API, Pharma Intermediate, or Specialty Fine Chemicals manufacturing workplace.
- Experience required for Officer Post: 2-4 years of experience in Regulatory Affairs within API, Pharma Intermediate, or Specialty Fine Chemicals manufacturing environment.
- In-depth knowledge of ICH guidelines, cGMP, and global chemical regulations (REACH/GHS).
- Strong technical writing and dossier preparation skills.
- Exceptional cross-functional coordination and communication skills to deal with international clients and regulatory agencies.
- High attention to detail, data integrity, and strict adherence to timelines.

📌 Officer / Executive - Regulatory Affairs (Surat)
🏢 ACUTAAS CHEMICALS
📍 Surat