Location: New Delhi, India (proximity to 3PL warehouse)
Reports to: Director, Product Compliance (solid line) Dotted line to: General Manager, India
Job Summary
We are looking for a seasoned, strategic Manager/ Senior Manager – Quality Assurance & Regulatory Affairs with deep domain expertise in the Indian cosmetics and dietary supplements/nutraceuticals sectors.
This high-impact leadership role is accountable for designing, implementing, and continuously enhancing a robust, risk-based Quality Management System (QMS) and regulatory compliance framework. The role ensures the highest standards of product quality, safety, and regulatory adherence across the end-to-end value chain — from sourcing and manufacturing to distribution and commercialization.
The incumbent will serve as a key business partner to senior leadership, proactively mitigating regulatory and quality risks, enabling faster and compliant product launches, and driving operational excellence in a dynamic, growth-oriented environment. Success in this role directly contributes to brand reputation, market access, and sustainable business growth in India.
Key Responsibilities
Strategic Quality Leadership & System Excellence
- Design, deploy, and continuously improve a comprehensive, risk-based Quality Management System (QMS) aligned with business objectives for cosmetics and dietary supplements.
- Champion adherence to GMP, GLP, ISO, and other relevant quality standards while embedding a strong quality and compliance culture across the organization.
- Oversee critical quality decisions, including approval of raw materials, packaging, artwork, finished goods, specifications, and third-party documentation.
- Lead internal audits, supplier audits, and third-party assessments; drive effective CAPA programs and preventive actions to minimize deviations and enhance overall quality performance.
Regulatory Strategy & Compliance Leadership
- Act as the primary accountable leader for full regulatory compliance with Indian authorities, including CDSCO (Cosmetics Rules and amendments), BIS standards, and FSSAI regulations for nutraceuticals, health supplements, and dietary supplements.
- Develop and execute regulatory strategies for product registrations, licenses, renewals, variations, and submissions to ensure timely market access and minimize compliance risks.
- Provide expert review and approval of formulations, labeling, claims, advertising, and promotional materials, ensuring scientific substantiation and full regulatory alignment.
- Proactively track, interpret, and assess evolving regulatory changes in India (and relevant international benchmarks); deliver strategic recommendations to leadership to support business agility and risk mitigation.
Supplier, Manufacturing & Commercialization Oversight
- Lead the qualification, onboarding, and ongoing governance of contract manufacturers (CMOs) and key suppliers in India, with a focus on building a resilient, high-quality supply chain.
- Drive manufacturing process compliance, technology transfers, scale-up, and new product commercialization initiatives to meet stringent quality, safety, and timeline requirements.
- Conduct regular risk assessments and supplier development programs to proactively address potential quality or regulatory vulnerabilities.
Documentation, Governance & Inspection Readiness
- Establish and maintain best-in-class documentation systems, including SOPs, specifications, COAs, batch records, and regulatory dossiers.
- Prepare executive-level quality and regulatory reports, KPIs, and dashboards for senior management and regulatory bodies.
- Lead preparation for, and successfully manage, regulatory inspections, audits by certification bodies, and internal compliance reviews.
Cross-Functional Influence & Leadership
- Collaborate closely with R&D, Procurement, Operations, Marketing, Legal, and Supply Chain as a trusted advisor, embedding quality-by-design and regulatory intelligence into all product development and launch processes.
- Provide strategic guidance, training, and influence to cross-functional teams and senior stakeholders to drive informed decision-making.
- Contribute to broader organizational initiatives around quality culture, continuous improvement, and operational excellence.
Qualifications & Experience
- Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or a related scientific field (advanced degree or certifications preferred).
- 10–15 years of progressive experience in Quality Assurance and Regulatory Affairs, with a minimum of 6–8 years in a senior or managerial capacity within the cosmetics, nutraceuticals, consumer health, or pharmaceutical industry in India.
- Proven track record of successfully managing regulatory approvals, launches, and compliance for cosmetics and/or dietary supplements in the Indian market.
- Strong hands-on experience with third-party manufacturing oversight and complex supply chains.
- Exposure to international regulatory frameworks (e.g., US FDA, EU Cosmetics Regulation) is highly advantageous.
Key Skills & Competencies
- Expert-level knowledge of Indian cosmetic and nutraceutical regulatory landscapes, with the ability to translate complex requirements into practical, business-enabling strategies.
- Strong leadership in audit execution, deviation investigation, root-cause analysis, and CAPA effectiveness.
- Excellent strategic thinking, analytical, problem-solving, and decision-making skills.
- Superior technical writing, documentation, and presentation abilities, including executive communication.
- Proven stakeholder management and influencing skills at all levels, including senior leadership and external regulatory authorities.
- Ability to thrive in fast-paced, ambiguous, high-growth environments with a proactive, solutions-focused, and results-orientented approach.
- Proficiency with digital quality and regulatory tools/systems.
Preferred Attributes
- Demonstrated success in launching multiple cosmetics and dietary supplement products in the Indian market.
- Balanced experience across both cosmetics and nutraceuticals categories.
- Background in startup, scale-up, or multinational FMCG/consumer health organizations.
- Relevant certifications (e.g., Lead Auditor, RAC, ASQ, or Six Sigma) and a strong network within Indian regulatory bodies.
