Regulatory Affairs & Compliance (Cosmetics)

Phitku Namastu Enterprise; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Phitku Namastu Enterprise seeks a Manager Regulatory Affairs & Compliance to own end-to-end regulatory compliance for cosmetics, personal care and food in India and export markets. You will anchor the Quality Management System for regulatory aspects, ensuring safe labelling, registrations and on-time launches.

You will lead the regulatory team, interact with regulators, prepare product dossiers, and track updates across FDA, EU, UK and Indian authorities to support market entry and ongoing

Qualifications

• 10–15 years in regulatory affairs/QA in cosmetics, personal care or FMCG.
• Hands-on experience with EU/US/UK regulatory requirements (PIF, CPSR, CPNP, MoCRA).
• Experience obtaining cosmetic licenses in India from CDSCO/State Authorities.

Responsibilities

• Own end-to-end regulatory compliance for cosmetics, personal care and food portfolios in India and export markets.
• Anchor QMS on regulatory side, manage audits and regulatory documentation.
• Lead, train and mentor regulatory team; coordinate with R&D, Marketing, Legal and Exports.

Skills

Regulatory strategy

Regulatory submissions

GMP/GDP awareness

Labeling & claims review

Regulatory portals熟悉

Tools

SUGAM portal

CPNP

FoSCoS

SCPN

Job description

Role purpose

The Manager Regulatory Affairs & Compliance owns end-to-end regulatory compliance for the company's cosmetic, personal care and food portfolio in India and in export markets (US, EU and UK). The role ensures every product is legally registered, safely formulated, correctly labelled and launched on time, with zero regulatory non-compliance.

The role also anchors the Quality Management System on the regulatory side, so that GMP, documentation and audits support approvals rather than delay them. It acts as the single point of contact with Indian regulators (CDSCO, State Licensing Authorities, FSSAI, Legal Metrology) and with overseas Responsible Persons, agents and authorities.

Key responsibilities – International cosmetic regulatory (US, EU, UK)

United States (US FDA)

• Ensure compliance with the Federal Food, Drug & Cosmetic Act and the Modernization of Cosmetics Regulation Act (MoCRA), including facility registration, product listing, safety substantiation and serious adverse event reporting.
• Review US labels against FDA cosmetic labelling rules (21 CFR 701) and the Fair Packaging and Labeling Act, including INCI ingredient declaration and net quantity.
• Identify products that qualify as OTC drugs (e.g. sunscreens, anti-dandruff, acne) and manage the applicable OTC monograph requirements.
• Screen formulations and claims for state-level requirements such as California Proposition 65 and the California Safe Cosmetics Program.

European Union (EU Cosmetics Regulation 1223/2009)

• Prepare and maintain Product Information Files (PIF) and coordinate Cosmetic Product Safety Reports (CPSR) with safety assessors.
• Manage CPNP notifications and work with the EU Responsible Person on post-market obligations.
• Check ingredients against Annexes II–VI (prohibited, restricted, colourants, preservatives, UV filters), allergen labelling, CMR substances and nanomaterial rules.
• Substantiate claims as per the EU common criteria for cosmetic claims (Regulation 655/2013).
• Ensure REACH, CLP and Safety Data Sheet compliance for raw materials and finished goods where applicable.

United Kingdom (UK Cosmetics Regulation)

• Manage SCPN notifications on the UK Submit Cosmetic Product Notification portal and maintain UK-specific PIFs.
• Coordinate with the UK Responsible Person and track divergence between UK and EU ingredient restrictions.

Across all export markets

• Build and execute the regulatory strategy for new product launches and market entry, including country-wise ingredient and claims feasibility.
• Review artwork and labels for every market before print release.
• Track regulatory updates (EU SCCS opinions, FDA/MoCRA rules, UK OPSS notices) and brief R&D and Marketing on impact and timelines.
• Manage export documentation such as Free Sale Certificates, Certificates of Analysis and GMP certificates.

Key responsibilities – India product registration & statutory compliance

Cosmetics (CDSCO / State FDA)

• Obtain, renew and maintain cosmetic manufacturing licences from the State Licensing Authority under the Drugs & Cosmetics Act, 1940 and Cosmetics Rules, 2020, including adding new products to licences.
• Manage import registration of cosmetics with CDSCO through the SUGAM portal, where the company imports products.
• Ensure formulations meet BIS standards and the ingredient restrictions applicable in India.
• Handle Ayurvedic / herbal product licensing under the Ayush provisions of the Drugs & Cosmetics Rules where the portfolio requires it.
• Face regulatory inspections, respond to observations and close them within the given timelines.

Legal Metrology (Weights & Measures)

• Obtain and maintain registration of manufacturer / packer / importer under the Legal Metrology (Packaged Commodities) Rules, 2011.
• Ensure every pack carries the mandatory declarations: net quantity, MRP, manufacturer/packer/importer details, month and year of manufacture, consumer care details and unit sale price.
• Handle Legal Metrology inspections, notices and compounding, and keep packaging teams updated on amendments.

Labels and claims (India)

• Approve all domestic artwork for cosmetic, food and Legal Metrology requirements before print.
• Review marketing and e-commerce claims against ASCI guidelines and applicable regulations.

Key responsibilities – Quality systems, audits & leadership

Quality Management Systems (preferred)

• Support implementation and upkeep of ISO 22716 (Cosmetic GMP), ISO 9001 and, for food, ISO 22000 / FSSC 22000 and HACCP.
• Own regulatory documentation control: SOPs, specifications, change control, deviation and CAPA linked to regulatory impact.
• Review BMR/BPR, stability and compatibility data, and Certificates of Analysis needed for dossiers.
• Manage market complaints, adverse event (cosmetovigilance) reports and product recalls with QA.
• Maintain natural / organic certifications (e.g. NPOP, COSMOS) where applicable.

Audits and vendors

• Plan and conduct internal, regulatory and third-party manufacturer / vendor audits; track observations to closure.
• Qualify raw material and packaging suppliers on regulatory documents (IFRA certificates, allergen statements, TDS, SDS, non-animal-testing declarations).
• Host customer, retailer and certification body audits.

Claims and safety support

• Coordinate with CROs and labs on clinical, dermatological and consumer perception studies to substantiate claims.
• Approve or reject claims based on available evidence for each market.

Cross-functional and team leadership

• Partner with R&D at the formulation stage so products are compliant by design for all target markets.
• Advise Marketing, Legal, Exports and Supply Chain on regulatory timelines and risks.
• Lead, train and develop the regulatory team; run regulatory awareness training for other departments.
• Maintain the master registration and licence tracker, with renewal alerts and audit-ready records.

Candidate profile & success measures

Must have

• 10–15 years in regulatory affairs and/or QA in cosmetics, personal care or FMCG.
• Hands‑on experience with EU PIF/CPSR, CPNP and UK SCPN notifications, and working knowledge of US FDA / MoCRA requirements.
• Proven record of obtaining cosmetic licences in India from State Licensing Authorities and/or CDSCO.
• Practical exposure to FSSAI licensing and food labelling, and to Legal Metrology registration and pack declarations.
• Strong skills in ingredient review (INCI), label and artwork review, and claims substantiation.

Good to have

• Certified ISO 9001 / ISO 22716 / ISO 22000 internal or lead auditor.
• Experience with Ayurvedic, natural or organic cosmetics (NPOP, COSMOS).
• Exposure to GCC, ASEAN or other export markets.
• Experience coordinating clinical and dermatological studies with CROs.

Skills and competencies

• Clear interpretation of regulations and the ability to turn them into practical guidance for R&D and Marketing.
• High attention to detail and disciplined documentation.
• Confident communication with regulators, Responsible Persons and senior management.
• Planning across many products and markets at once; ability to meet launch deadlines.
• Team leadership, training and mentoring.
• Proficiency in MS Office; familiarity with regulatory portals (SUGAM, FoSCoS, CPNP, SCPN, FDA Cosmetics Direct).