Officer / Executive - Regulatory Affairs

ACUTAAS CHEMICALS LIMITED; Surat; On-site; INR 900,000 - 1,300,000; Full time

Job summary

ACUTAAS CHEMICALS LIMITED is seeking a Regulatory Affairs professional to manage dossier preparation and global regulatory compliance. You will coordinate with R&D, QC, QA, and Production to gather data for new products and process changes, while handling audits and CAPA actions.

The role requires in-depth knowledge of ICH, cGMP and REACH/GHS, with strong technical writing and international client communication skills. A detail-oriented, timely professional is essential for this position.

Qualifications

• Experience of 5-7 years in Regulatory Affairs within API, Pharma Intermediate, or Specialty Fine Chemicals manufacturing environment.
• Experience of 2-4 years in Regulatory Affairs for Officer post.
• In-depth knowledge of ICH guidelines, cGMP, and global chemical regulations (REACH/GHS).
• Strong technical writing and dossier preparation skills.

Responsibilities

• Prepare, review, and maintain regulatory documents (DMFs, CEPs, CoA) conforming to global standards.
• Manage registrations and compliance with cGMP, ISO standards and statutory laws.
• Respond to regulatory inquiries from global customers and coordinate data for launches or process changes.
• Assist in internal audits, regulatory inspections, and CAPA for documentation gaps.
• Monitor regulatory changes and assess impact on portfolios.

Skills

Regulatory affairs

Cross-functional coordination

Technical writing

Attention to detail

Data integrity

Education

B.Sc./M.Sc in Chemistry (Chemistry/Organic Chemistry)

Job description

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 environment.
• 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.