Job Description Summary
Provides regulatory and operational support for existing third-party customer FDF portfolios across global markets, ensuring compliant maintenance of Marketing Authorizations and timely execution of regulatory changes in line with business and regulatory requirements.
Job Description
Position Purpose:
Provides regulatory and operational support for existing third-party customer FDF portfolios across global markets, ensuring compliant maintenance of Marketing Authorizations and timely execution of regulatory changes in line with business and regulatory requirements.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Manage lifecycle maintenance activities for existing Marketing Authorizations for third-party customer products, ensuring continued regulatory compliance across global markets. Coordinate cross-functional internal stakeholders, including Regulatory Affairs, Quality, Production, and Supply Chain, as well as relevant third-party customer counterparts,
to assess regulatory impact and support compliant implementation of changes
Manage and coordinate maintenance-related regulatory activities with third-party customers to ensure timely and seamless implementation of variations, updates, notifications, and other ongoing business requirements
Prepare, maintain, and oversee regulatory documentation and records to ensure accuracy, completeness, inspection readiness, and alignment with regulatory standards, data integrity expectations, and internal governance requirements.
Monitor relevant global and local regulatory requirements and legislative changes affecting existing products, ensuring Marketing Authorizations remain current and compliant
Provide regulatory, product-related, and compliance-related support within the B2B organization for existing business activities
Build and maintain effective working relationships with internal and external stakeholders to support aligned and effective execution