Perfume/Personal Care - Regulatory Affairs Senior Executive

• Well versed with all Regulatory operational standards and procedures and regulatory compliance for the product labels country wise.
• Very good knowledge in international regulatory requirements for US FDA, EU, ASIAN, MIDDLE EAST countries.
• Knowledge and understanding of regulatory compliance procedures of personal care products.
• Being able to prepare various certificates such as COA (Certificate of Analysis), MSDS, QQF, Certificate of No Animal Testing, Certificate of GMP, Certificate of Impurities,
• Free Sales Certificates as per Customer’s requirement.
• Knowledge on customer complaint handling. Well versed in checking the label, text and artworks as per the EU, US FDA, ASIAN, GSO regulatory requirements.
• Studying Legal Documents and collating information in a variety of formats.
• Ensuring compliance with regulations set by the Cosmetics & Perfumes Regulatory Agency as per country wise requirements.
• Keeping up to date with changes in regulatory legislation and guidelines
• Outlining requirements for labelling, storage and packaging. Maintain product drawing/Artworks/ documents distribution record.
• Maintain the MSDS, QQF which are required for the customer’s country wise.
• Responsibilities include record keeping, all documents such as specification procedures, inspection schedule and records to QC/QA procedures.
• Preparation of Specification for In-Process, Intermediate, Raw material (RM), Packaging material (PM) testing as per regulatory requirement.
• Preparation of Test Data Sheet for Intermediate, Raw material, Packaging material & Stability Testing. 
• To review and prepare Impact Assessment / Risk Assessment report. 
• Maintain and support procedures to ensure the compliance of all cosmetic products and packaging.
• Gather and maintain data for raw materials and production batches ensuring GMP and customer compliance.
• Prepare accurate, complete documentation in a timely manner as necessary.
• Preparation of product specifications.
• Receiving and getting approval of the final art works for their color text, legal requirements as per the customers’ / Country wise regulatory requirement.
• Updating the legal requirements and checking the art works as per the legal requirements for the various countries / customers.
• Preparation of the various certificates like COA, certificate of no animal testing, certificate of GMP, certificate of impurities, free sale certificate as per the customer’s requirement.
• To constantly engage researching new regulation updates and should be able to take pro-active action with respect to the updating of the formulation,
• Artwork and labelling for non- compliant products.

Skills & Competencies Required:

• Must have a thorough knowledge of the regulatory documentation requirements for the personal care industry.
• Should be well versed with US FDA, EU regulatory requirements.
• Should be well versed in the preparation of MSDS, COA, PIF and CPNP files.
• Very good knowledge on Indian Drug & Cosmetic manufacturing Act especially on Schedule S Standards & GMP.
• User knowledge in JD Edwards / MS windows.
• Problem Solving. Result Orientation
• Environmental monitoring. Knowledge of Calibration of Instruments. Documentation and reporting
• Knowledge of Cosmetic RM/ PM stability Tests. Analytical and attention to details.