AM - QA Regulatory (Haridwar)

Job Description:

1. Experience in handling Import Registration with CDSCO
2. Knowledge of European regulation for Export Purpose.
3. Knowledge of MoCRA
4. Knowledge of Regulatory requirement of Fragrances and its Alleergen.
5. Knowledge of ISO16128 ISO 16128-1:2016 Guidelines.
6. Knowledge of Prop 65, Sephora Clean.
7. Knowledge of BIS.

Regulatory Compliance

• Ensure compliance of cosmetic products with applicable Indian regulations, including Cosmetics Rules, 2020 and Drugs & Cosmetics regulatory requirements.
• Monitor changes in CDSCO, BIS and other applicable regulatory requirements and communicate their impact to relevant departments.
• Maintain regulatory compliance for the complete product portfolio.
• Support regulatory audits, inspections and queries from regulatory authorities.

2. Product Regulatory Assessment

• Review formulations and raw materials from a regulatory perspective.
• Assess new product concepts against applicable cosmetic standards and regulatory requirements.
• Review product specifications, test reports, COAs, MSDS/SDS and other technical documents.
• Identify regulatory risks during product development and recommend corrective actions.

3. Artwork, Label & Claims Review

• Review product labels, packaging artwork, cartons, leaflets and promotional materials.
• Ensure compliance of ingredient declarations, product claims, warnings, directions for use, batch information and other mandatory declarations.
• Evaluate cosmetic claims and ensure that claims are appropriately supported and are not misleading.
• Coordinate with Marketing, R&D, Packaging and Quality teams for timely artwork approvals.

4. Regulatory Documentation

• Prepare and maintain regulatory dossiers and product documentation.
• Maintain product registration, licenses, approvals, declarations and compliance records.
• Ensure proper document control and timely renewal/update of regulatory documents.
• Prepare regulatory status reports and maintain trackers for submissions and approvals.

5. New Product Development (NPD) Support

• Provide regulatory inputs to R&D during formulation and product development.
• Review ingredients, formulations, product specifications and claims before commercialization.
• Support regulatory clearance of new launches within agreed timelines.
• Coordinate with R&D, QA/QC, Supply Chain, Packaging and Marketing teams.

6. Regulatory Submissions & Authority Coordination

• Prepare and coordinate regulatory submissions wherever applicable.
• Liaise with regulatory consultants, manufacturers, laboratories and government authorities.
• Track submissions, queries, approvals and pending regulatory actions.
• Prepare responses to regulatory queries and ensure closure within timelines.

7. Compliance & Audit Support

• Support internal and external regulatory audits.
• Ensure regulatory documents are readily available and updated.
• Assist in investigation and closure of regulatory non-compliances.
• Participate in CAPA and change-control activities having regulatory impact.

8. Regulatory Intelligence

• Continuously monitor changes in Indian cosmetic regulations, BIS standards and relevant notifications.
• Assess the impact of new regulations on existing products and business operations.
• Maintain a regulatory update database and communicate important changes to stakeholders.

Required Qualification

• B.Pharma / M.Pharma
• M.Sc./B.Sc. Chemistry, Life Sciences or related scientific discipline may also be considered.
• Additional certification in Regulatory Affairs/Cosmetics Regulatory Affairs will be an advantage.