Senior Quality & Regulatory Manager

Beiersdorf; Mumbai; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

NIVEA India Pvt. Ltd. is seeking a Quality & Regulatory Manager to oversee country-specific regulatory requirements and ensure product compliance across markets. You will lead regulatory filings, monitor developments, and liaise with regulatory authorities as the primary contact for quality matters.

The role covers GMP audits, supplier quality management, and training of internal and external stakeholders on QMS. Strong English communication and 7–10 years in relevant fields are essential.

Qualifications

• Bachelor's or Master's degree in Science, Pharmacy, or related field.
• 7–10 years of experience in Quality Management and Regulatory Affairs.
• Experience in FMCG/pharma/cosmetics sector preferred.
• Excellent command of English with strong stakeholder management.

Responsibilities

• Regulatory compliance: ensure products meet local requirements and label/advertising rules.
• Product registrations: handle local and imports regulatory filings with authorities.
• Regulatory communication: monitor developments and advise QM Market Compliance.
• Quality Management System: implement and audit GMP, SQM processes, supplier audits.
• Sourcing: support local materials and supplier quality evaluations.

Skills

Analytical

Coordinating

Communication

Presentation

Education

Bachelor's or Master's degree in Science, Pharmacy, or related field

Post Graduate Diploma in Drug Regulatory Affairs

Job description

Job Details

• Contract Type: Unlimited / Full-Time
• Country / City: India / Mumbai
• Company: NIVEA India Pvt. Ltd.
• Job Function: Quality Management

Your Tasks

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.

Your Profile

• -Education: Bachelor's or Master's degree in Science, Pharmacy, or a related field. A Post Graduate Diploma in Drug Regulatory Affairs will be an added advantage.
• -Experience: 7-10 years of experience in Quality Management and Regulatory Affairs, preferably within the FMCG, pharmaceutical, healthcare, or cosmetics industry.
• -Language Skills: Excellent command of spoken and written English, with strong communication and stakeholder management abilities.

Additional information

For any queries, reach out to Kartik Kulshrestha - TA Lead.