Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for managing and executing all regulatory affairs activities within the assigned Bayer Pharma portfolio and/or geography. This includes: Providing functional leadership and governance in regulatory planning and strategy aligned with business objectives Managing licensing, maintenance, and change management for imported, local, and export-market products (pharmaceuticals and medical devices) Supervising junior RA staff for lifecycle management activities (renewals, CMCs) when required Ensuring timely registration and label compliance for new chemical/biological entities (NCE/NBE), new indications, and line extensions Maintaining full awareness of all regulatory activities and deadlines for assigned portfolio Ensuring products comply with regulatory, corporate, legal, and local requirements throughout the product lifecycle Working closely with local, regional, and global stakeholders to achieve optimal outcomes Maintaining required licenses for company functioning (e.g., GMP certificate, manufacturing license)