17 Oct
|
Beiersdorf
|
Maharashtra
17 Oct
Beiersdorf
Maharashtra
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 significant 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.
📌 Senior Quality & Regulatory Manager (Maharashtra)
🏢 Beiersdorf
📍 Maharashtra