Line Manager / Regulatory Affairs Manager Spain

What to Expect

• Line management, training of Regulatory Specialist
• Training of the direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Engage with regulatory authorities and distribution partners to support product registrations
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
• Support and participate in inspections and audits conducted by global regulatory authorities.