Manager- Regulatory & Quality

Job Title: Manager – Regulatory & Quality

Reporting To: Head of Operations.

Job Summary:

This role provides strong regulatory oversight to ensure compliance with MOCRA, USFDA Cosmetic regulations, and US market requirements , while supporting product development, technology transfer, and continuous improvement initiatives.

Also responsible for leading quality systems, quality operations, supplier quality, and audit readiness for all the US Namaste Products.

Qualifications, Experience & Skills:

• Master’s degree in chemistry, Pharmacy, Biotechnology, Microbiology or related discipline .
• 10–12 years of experience in Cosmetics, Personal Care, FMCG, or Pharmaceutical Manufacturing , with US market exposure.
• Strong working knowledge of MOCRA, USFDA cosmetic regulations (21 CFR), GMP, and quality systems .
• Experience supporting or handling USFDA inspections, observations, and regulatory queries .
• Proficiency in ERP/SAP, QMS, Safety Data sheet, and documentation control systems .
• Prior experience in R&D, validation, technology transfer, or NPD preferred.
• Knowledge of CPNP (EU), SCPN (UK), and global cosmetic regulations .
• Strong analytical, documentation, communication, and stakeholder management skills.

Key Responsibilities:

Regulatory & Market Compliance:

• Ensure site-level compliance with MOCRA requirements, including GMP alignment, record retention, adverse event handling support, and inspection readiness.
• Act as the quality focal point for USFDA-related interactions, audits, and inspections.
• Supports USFDA clearance of shipments, addressing quality, documentation, or compliance queries.
• Review and ensure compliance of Raw material specifications, formulations, and finished products with US regulatory requirements.
• Ensure label review and compliance (Ingredients, Claims, warnings) in coordination with Regulatory Affairs.
• Maintain inspection-ready documentation and support timely response to USFDA observations (483s), inquiries, and follow-ups.

R&D and New Product Development:

• Collaborate closely with R&D to support new product trials, scale-up, and formula transfer to other manufacturing locations / 3Ps.
• Provide quality input on formula design, ingredient selection, packaging compatibility, and stability studies .
• Support troubleshooting, investigations, and process optimization for new and existing products.
• Ensure R&D documentation aligns with quality systems and regulatory expectations .

Quality Assurance and Audit & Compliance:

• Coordinate and support internal and external audits
• Ensure continuous compliance with GMP, product quality, quality systems, and applicable regulatory standards .
• Manage and review supplier quality documentation , ensuring alignment across the supply chain.
• Support regulatory inspections and customer audits, including USFDA - related interactions where applicable.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance product quality, process efficiency, and cost optimization.

Key Competencies:

• Quality leadership & decision-making
• Regulatory & compliance expertise
• Cross-functional collaboration
• Risk assessment & problem-solving
• Strong documentation & communication skills