Manager, Regulatory Affairs - India

Overview

Role at a glance:

Ensure product formulation compliance in accordance with:

• FSS Act, Rules, and Guidelines
• Ayurveda under Ayush Regulations
• Cosmetics governed by the Drugs & Cosmetics (D&C) Act and Rules

Maintain labelling compliance as per:

• FSS Act, Rules, and Guidelines
• Legal Metrology (Packaged Commodities) Rules
• Ayurveda and Drugs & Cosmetics (D&C) legislation and regulations

Provide timely regulatory advocacy to cross-functional teams and support business objectives by meeting regulatory requirements. Actively collaborate with QA/QC and R&D teams on formulation, product development, and ensuring quality and safety parameters. Drive timely implementation of new regulatory provisions to maintain compliance. Demonstrate proficiency in Agile applications for efficient documentation and workflow management.

How you’ll make an impact:

• Ensure overall regulatory compliance for the entire product portfolio, including formulation assessment, claims evaluation, label content preparation, artwork review, and approval processes.
• Collaborate closely with the Product Development, Marketing, and Scientific Affairs teams to align regulatory requirements.
• Provide regulatory mentorship during product development, categorization, and coordinate with Quality, Food Safety, Scientific Affairs, Marketing, and Legal teams for artwork and claims development.
• Support and assist the team lead in various operational activities.
• Take complete ownership of product portfolio management within the AGILE framework.
• Coordinate licensing activities and dossier preparation, ensuring timely availability of product licenses, endorsements, and related approvals for product launches.
• Review and approve all promotional materials in consultation with the team, including advertising flyers, videos, booklets, pamphlets, training materials, and presentations.
• Monitor, guide, and support team members, and coordinate periodic meetings to ensure alignment and progress.

Qualifications for success:

Education:

• BSc or equivalent experience, MSc or equivalent experience (Food Tech, or any Life Science’s stream) B. Pharma/M. Pharma/BAMS (Ayurveda)

Experience:

• 10+ years

Skills/Certifications:

• Core Regulatory Skills:

1. Regulatory submission & documentation

• Technical & Analytical Skills:

1. Regulatory Risk assessment

• Cross-functional & Communication Skills:

1. Training & regulatory mentorship - Educating internal teams on new regulations and impact.