Head Regulatory Affairs

Rossari Biotech Limited; Mumbai; On-site; INR 2,800,000 - 5,200,000; Full time

Job summary

Rossari Biotech Limited in Mumbai is seeking a seasoned Regulatory Affairs professional to lead regulatory strategy and chemical compliance across global markets. You will own SDS and regulatory documentation, ensuring adherence to GHS/REACH/CLP/OSHA and related frameworks.

Collaborating with Quality, R&D, Manufacturing, Supply Chain and Sales, you will support certifications (RSPO/OMRI), coordinate with authorities, and manage regulatory data exchanges.

Qualifications

• Experience in regulatory affairs and chemical compliance within chemical/pharma/ingredient manufacturing sectors.
• Strong knowledge of global chemical regulations (GHS, REACH) and industry standards (OMRI, RSPO).
• Experience using SDS authoring software and maintaining version-controlled documentation.
• Excellent attention to detail and ability to manage external regulatory correspondence.

Responsibilities

• Lead regulatory affairs and chemical compliance activities for the organization.
• Monitor global/regional regulations and assess impact on products.
• Ensure compliance with GHS, REACH, CLP, OSHA and other frameworks.
• Establish regulatory processes, controls and documentation standards.
• Act as internal subject-matter expert for regulatory requirements.
• Own preparation, review and maintenance of Safety Data Sheets (SDS).
• Manage SDS revisions, version control and documentation history.
• Coordinate with customers, suppliers and regulatory authorities on REACH & regulatory data exchange.
• Provide regulatory declarations and compliance statements, support customer audits and questionnaires.
• Work closely with Quality, R&D/Technical, Manufacturing, Supply Chain, Sales, Procurement, EHS, and Regulatory teams.
• Support/lead industry certifications and maintain RSPO and OMRI documentation.
• Prepare Pharma Tech Packs and support regulatory filings and customer qualification processes.
• Resolve regulatory issues affecting shipments and provide documentation for customs clearance.

Skills

Regulatory affairs

Chemical compliance

GHS/REACH/CLP/OSHA

SDS management

Regulatory documentation

Cross-functional coordination

Regulatory communications

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmacy/Environmental Science

Tools

SDS authoring software

Chemical management databases

Job description

Role & responsibilities

Key Responsibilities

A. Regulatory Strategy & Compliance

• Lead regulatory affairs and chemical compliance activities for the organization.
• Monitor applicable global/regional chemical regulations and assess their impact on products.
• Ensure compliance with GHS, REACH, CLP, OSHA and other relevant regulatory frameworks.
• Establish regulatory compliance processes, controls and documentation standards.
• Act as the internal subject-matter expert for regulatory requirements.

B. SDS & Regulatory Documentation

• Own preparation, review and maintenance of Safety Data Sheets (SDS).
• Ensure SDS are compliant with applicable regional/global regulations.
• Manage SDS revisions, version control and document history.
• Review product classification and hazard communication information.
• Maintain regulatory databases and documentation.

C. REACH & Chemical Compliance

• Manage REACH-related correspondence and regulatory data exchange.
• Coordinate with customers, suppliers and regulatory authorities.
• Track regulatory requirements and product compliance status.
• Support registration/compliance-related activities where applicable.
• Ensure regulatory information is available for commercial and supply-chain requirements.

D. Customer & Commercial Regulatory Support

• Provide regulatory declarations and compliance statements.
• Handle customer-specific regulatory documentation.
• Support customer audits/questionnaires.
• Resolve urgent regulatory documentation requests.
• Partner with Sales and Commercial teams to close regulatory queries within customer SLAs.

E. Cross-functional Regulatory Coordination

Work closely with:

• Quality
• R&D / Technical
• Manufacturing
• Supply Chain
• Sales
• Procurement
• EHS
• Regulatory teams

F. Certifications & Special Regulatory Programs

• Support/lead relevant industry certifications.
• Manage documentation for certifications such as RSPO and OMRI.
• Maintain certification records and renewal documentation.
• Coordinate with internal stakeholders and certification bodies.

G. Pharmaceutical / Technical Documentation

• Prepare and maintain Pharma Tech Packs.
• Coordinate technical and regulatory data required for pharmaceutical product qualification.
• Support regulatory filings and customer qualification processes.

H. Regulatory Support to Supply Chain

• Resolve regulatory issues affecting shipments.
• Provide documentation required for customs/customer clearance.
• Prevent shipment delays arising from regulatory documentation gaps.
• Coordinate urgent regulatory requests with Supply Chain and customers.

Preferred candidate profile

• Education: Bachelors degree in Chemistry, Biochemistry, Pharmacy, Environmental Science, or a related technical discipline.
• Experience: 9 to 11 years of experience in regulatory affairs, chemical compliance, or quality assurance within the chemical, pharmaceutical, or ingredient manufacturing sectors. Technical & Soft Skills
• Strong working knowledge of global chemical regulations (GHS, REACH) and industry standards (OMRI, RSPO).
• Experience using SDS authoring software and chemical management databases.
• Exceptional attention to detail with proven experience managing version-controlled documentation.
• Strong communication skills to manage external correspondence with regulatory authorities and high-value customers. Ability to work under pressure to resolve supply chain blocks or meet strict customer SLAs