Head – Compliance & Regulatory Affairs

Hitachi, Ltd.; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Scimplify is seeking an experienced Head - Compliance & Regulatory Affairs to build and lead the regulatory function for specialty chemicals, agrochemicals, pharmaceutical intermediates, and APIs. This role will shape the compliance framework, manage registrations, and drive global market expansion.

Responsibilities include overseeing regulatory submissions, documentation, risk management, and cross-functional partnerships with R&D, quality, manufacturing, and supply chain.

Qualifications

• 12+ years in regulatory affairs or chemical compliance leadership.
• Strong knowledge of global chemical regulations (GHS, REACH, TSCA).
• Experience with agrochemicals, pharma intermediates, or contract manufacturing.

Responsibilities

• Develop and implement regulatory and compliance framework aligned with Scimplify's expansion plans.
• Ensure compliance with domestic Indian and international chemical regulations (REACH, TSCA, GHS/CLP).
• Oversee product registrations, documentation, SDS, and labeling across markets.
• Lead audits, risk assessments, and regulatory submissions; manage regulatory data/queries.

Skills

Regulatory leadership

Chemical compliance

Global regulations

GHS/SDS

EU REACH/UK REACH

US TSCA

Agrochemicals

Contract manufacturing

Stakeholder management

Job description

Scimplify is a science-first manufacturing company for Advanced Materials: from specialty chemicals to the emerging building blocks of next-generation energy applications, life sciences, and crop sciences.

We scale process development and manufacturing as one continuous system, supported by world-class R&D infrastructure and executed across a global network of 500+ manufacturing partners and thousands of scientists and technical partners. The result: new materials go from molecule to commercial scale in months, not years. Scimplify operates offices and teams across 5 countries with 1,000+ innovator customers in 40+ countries.

We are backed by investors such as Accel, Bertelsmann, Omnivore, Hitachi Ventures and 3one4 Capital, having raised over $80M.

Role Overview

Scimplify is looking for an experienced Head - Compliance & Regulatory Affairs to lead and build the company’s regulatory and compliance function across its specialty chemicals, agrochemicals, pharmaceutical intermediates, and contract manufacturing businesses.

The role will be responsible for establishing a robust compliance framework, ensuring adherence to applicable domestic and international chemical regulations, managing product registrations and regulatory documentation, and working closely with R&D, manufacturing, quality, supply chain, and commercial teams to enable compliant business expansion across global markets.

Key responsibilities

• Regulatory Strategy: Develop and implement a comprehensive regulatory and compliance framework aligned with Scimplify's business operations and international expansion plans.
• Chemical Regulatory Compliance: Ensure compliance with applicable regulations, including REACH, UK REACH, TSCA, GHS/CLP, and other relevant chemical control regulations, depending on product and market requirements.
• Product Stewardship: Oversee product classification, hazard communication, SDS preparation and review, chemical labelling, safety documentation, and regulatory data management.
• Agrochemical & Pharmaceutical Compliance: Provide regulatory oversight for relevant agrochemical active ingredients, intermediates, pharmaceutical intermediates, and APIs, where applicable to the business.
• Domestic Compliance: Ensure adherence to applicable Indian environmental, chemical handling, storage, transportation, import-export, and industrial regulatory requirements.
• Manufacturing & Supplier Compliance: Establish compliance requirements for contract manufacturing partners, suppliers, and third-party facilities; conduct assessments and coordinate audits where required.
• Import, Export & Trade Compliance: Support cross-border trade through regulatory classification, documentation, restricted-substance screening, and applicable import-export requirements.
• Regulatory Documentation & Registrations: Manage regulatory submissions, product dossiers, declarations, customer questionnaires, certificates, and supporting technical documentation.
• Audit & Risk Management: Establish internal compliance audits, risk assessments, corrective and preventive action processes, and systems to monitor regulatory changes.
• Cross-functional Leadership: Partner with R&D, quality, manufacturing, procurement, legal, and commercial teams to integrate regulatory requirements into product development, sourcing, manufacturing and market entry.
• Team & Process Development: Build the regulatory team, standard operating procedures, compliance systems, and governance processes required to support business growth.

Desired candidate profiles

• 12+ years of experience in regulatory affairs, chemical compliance, product stewardship, or regulatory leadership within the chemicals or related industries.
• Strong knowledge of global chemical regulations, hazard classification, GHS, SDS authoring and management, and chemical product compliance.
• Experience with international regulatory frameworks such as EU REACH, UK REACH, US TSCA, and applicable regional chemical regulations.
• Exposure to agrochemicals, specialty chemicals, pharmaceutical intermediates, APIs, or contract manufacturing environments.
• Experience managing regulatory documentation, supplier compliance, customer audits, regulatory assessments, and cross-border trade requirements.
• Proven ability to establish compliance processes and manage regulatory risks in a growing or complex business environment.
• Strong stakeholder management, analytical, communication, and team leadership skills.

Preferred Background:

Specialty chemicals, agrochemicals, chemical manufacturing, CDMO/contract manufacturing, pharmaceutical intermediates, or product stewardship organisations.

Key success matrics

• Establishment of a scalable regulatory and compliance framework.
• Compliance readiness across domestic and international markets.
• Timely completion of regulatory documentation and submissions.
• Reduction of compliance risks and non-conformities.
• Improved supplier and manufacturing partner compliance.
• Effective support for new product launches and market expansion.

A strategic and hands-on regulatory leader who can build Scimplify's compliance function, translate complex regulatory requirements into practical business processes, and enable safe, compliant, and sustainable growth across domestic and global markets.