Manager - Regulatory Affairs (4-6 yrs)

About the Role:

- We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our dynamic team.

- This is a full-time, on-site position that requires strong knowledge of global regulatory requirements, particularly in the cosmetics industry, specifically colors, pigmentation, and dyes.

Key Responsibilities:

Regulatory Compliance & Global Management:

- Ensure adherence to global regulatory standards and guidelines.

- Monitor and interpret regulatory changes and their impact on product development and commercialization.

- Develop and implement global regulatory strategies to support business objectives.

Licensing & Product Registration:

- Oversee the licensing and registration process for new and existing products in various markets.

- Prepare and submit regulatory dossiers, including technical documentation and safety assessments.

- Manage product notifications and renewals to maintain market access.

CAPA Coordination with Factory:

- Collaborate with the factory to implement corrective and preventive actions (CAPAs) to address regulatory issues.

- Ensure timely completion of CAPAs and maintain effective communication with the factory.

Technical Documentation:

- Develop, review, and approve technical documentation, such as product information files, safety data sheets, and labeling.

- Ensure accurate and up-to-date technical documentation.

Product Compliance and Risk Assessment:

- Conduct product safety assessments and risk assessments to ensure compliance with regulatory requirements.

- Monitor product performance and address any potential safety concerns.

Cross-functional Coordination:

- Collaborate with various departments, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance throughout the product lifecycle.

Audits and Inspections:

- Coordinate and participate in regulatory audits and inspections.

- Prepare for and respond to regulatory authority inquiries.

Labeling and Documentation Control:

- Manage labeling and packaging design to ensure compliance with regulatory requirements.

- Implement and maintain effective document control systems.

Qualifications:

- Bachelor's or Master's degree in Chemistry, Chemical Engineering, or a related field.

- 4-6 years of experience in regulatory affairs within the colors, pigmentation, or dye industry.

- Strong understanding of global regulatory requirements, particularly in the EU, US, Canada, and other ROW markets.

- Proficiency in regulatory standards and technical documentation requirements.

- Familiarity with KAPA processes.

- Excellent communication, analytical, and project management skills.

- Ability to collaborate with cross-functional teams and manage complex documentation.

Additional Preferred Qualifications:

- Experience with SAP or other ERP systems.

- Certifications in regulatory affairs (e.g., RAC, RP).

- Fluency in multiple languages