Job Description

Positions: Associate General Manager - CQA Regulatory
Role Summary:
As the Associate General Manager - CQA Regulatory, you will be responsible for overseeing and ensuring regulatory compliance for skincare product development and delivery. You will act as a key link between R&D, Quality, Regulatory bodies, and Marketing to ensure that skincare formulations are compliant, safe, efficacious, and market-ready.
Key Responsibilities:
1. Regulatory Strategy & Compliance
Lead regulatory strategy for new skincare product development across domestic and global markets (India, EU, US, ASEAN, etc.)
Ensure compliance with regulatory guidelines such as BIS, CDSCO, FDA, ISO 22716, and relevant cosmetic regulations.
Prepare and review regulatory documentation including PIFs, CPSRs, COAs, MSDS, label claims, etc.
Liaise with regulatory bodies and manage product registrations, renewals, and audits.
2. R&D Design & Delivery Support
Work closely with R&D teams to validate product formulations, ingredients, and preservatives based on safety and regulatory standards.
Guide formulation teams on ingredient acceptability, label compliance, banned/restricted substances, and claims substantiation.
Support innovation projects by providing regulatory feasibility and compliance checks at concept and formulation stages.
3. Quality Assurance Integration
Partner with Quality Assurance to ensure GMP practices, raw material traceability, and stability protocols are in place.
Drive cross-functional quality review processes and implement CAPAs as needed based on audits or risk assessments.
Review vendor qualifications, material certifications, and third-party lab results for regulatory alignment.
4. Labeling & Claims Review
Approve product artworks, labels, outer cartons, and marketing materials from a regulatory standpoint.
Ensure all claims (e.g., dermatologically tested, clinically proven, non-comedogenic, etc.) are backed by scientific data and permitted under cosmetic regulations.
Coordinate with clinical testing teams for necessary efficacy and dermatology study reports.
5. Documentation & Audits
Maintain a central repository of regulatory filings, approvals, and technical dossiers for each product.
Lead internal audits and regulatory inspections, and coordinate responses to regulatory queries or notices.
6. Team Leadership & Stakeholder Management
Manage and mentor a team of regulatory officers/executives.
Act as a liaison between R&D, Marketing, Packaging, Legal, and Commercial teams.
Represent the company in industry forums and regulatory meetings when required.
Required Qualifications:
M. Pharm / M.Sc. in Cosmetic Science, Pharmaceutical Sciences, Chemistry, or related field.
10-15 years of experience in Regulatory Affairs, QA, or R&D within Cosmetics, Skincare, or Personal Care industries.
Strong knowledge of global cosmetic regulations (BIS, EU Cosmetics Regulation, US FDA, ASEAN, etc.)
Proficiency in dossier preparation, ingredient database review (CosIng, PCPC, etc.), and regulatory software tools.
Excellent communication, analytical thinking, and leadership skills.
Preferred Skills:
Exposure to clinical study protocols and toxicological risk assessment.
Experience with SAP, Trackwise, or regulatory documentation platforms.
Strong understanding of product lifecycle management from ideation to shelf.