Overall Obligation:

The Quality & Regulatory Manager will be responsible for managing country-specific regulatory requirements and ensuring product compliance with all applicable regulations. The role will serve as the primary point of contact for all quality and regulatory matters.

Role and Responsibilities:

1. Regulatory Compliance

-Ensure that products meet local regulatory requirements.
-Compliance of country artworks with master artworks and local labelling requirements.
-Compliance of advertisements, especially use of claims, with local advertising requirements.
-Compliance with sales channel restrictions

2. Product Registrations (Local and Imports)

-Identify and manage local registration and variation requirements, liaising with QM Market Compliance for required documentation.
-Adapt and submit registration dossiers and product information to local authorities in the required format and language.
-Coordinate registration of locally produced and imported products with relevant authorities.
-Follow up with regulatory authorities (FDA, DCGI, Port Authorities, etc.) and maintain all product registrations.

3. Regulatory Communication

-Monitor regulatory developments and requirements/recommendations at the country level and communicate important issues to Corporate Quality Management (Market Compliance, External Relations) in a timely manner.
-Keep External Relations informed about the regulatory status of specific ingredients (e.g., preservatives, active ingredients) to enable information transfer into the discovery phase.
-Establish contacts with local authorities and act as the primary contact for regulatory issues and troubleshooting.
-Provide reliable information on local requirements upon request from QM Market Compliance within IIM (e.g., product classification, regulatory clearance, specific packaging requirements).

4. Quality Management System

-Ensure effective implementation and execution of BDF requirements for suppliers regarding warehouses, transport, VAS, 3PMs, and packaging.
-Manage quality-related activities such as inspection, release, non-conformity handling, blocking, relabelling, returns, and disposal of products.
-Train all internal and external stakeholders on Quality Management systems.
-Execute GMP audits at supplier sites, ensure timely accomplishment of corrective and preventive actions, and negotiate quality agreements.
-Audit 3PMs, VAS providers, and warehouses at regular intervals and ensure compliance with the QMS Manual.

5. Sourcing

-Support local sourcing activities for raw materials, packaging materials, finished products, and services (warehousing) in IIM and non-IIM projects regarding all quality-related tasks.
-Represent Quality Management in supplier evaluation, assessment, release, and onboarding activities.
-Execute GMP audits at new supplier sites, ensure timely accomplishment of corrective and preventive actions, and negotiate quality agreements.
-Ensure effective implementation of the FFPR product release process and train suppliers accordingly.
-Act as the single point of contact for supplier-related troubleshooting activities.

Managerial Competencies

-Analytical: Methodical, systematic, and strong logical reasoning skills.
-Coordinating: Motivates and empowers others to achieve organizational goals.
-Communication: Speaks clearly, fluently, and effectively to both individuals and groups. Writes in a clear and concise manner using appropriate style and language.
-Presentation: Proficient in PowerPoint presentations.