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