Affaires Reglementaires jobs in France

Rate: Market Rates

Location: EU (Remote)

Duration: 6 months+

• Develop and execute regulatory strategies for advertising and promotion, across designated therapeutic areas and product lines.
• Provide expert guidance to marketing, medical, and commercial teams to ensure compliance with local regulatory requirements and alignment with strategic objectives.
• Oversee the review and approval of promotional materials, including advertisements, brochures, digital content, social media campaigns, and educational materials, ensuring they meet regulatory standards and company policies.
• Develop and implement internal guidelines and processes for the creation, review, and approval of promotional content to ensure consistent regulatory compliance.
• Ensure that promotional claims are accurate, substantiated with clinical or scientific evidence, and compliant with EMA, and other global regulatory guidelines.
• Evaluate the effectiveness and regulatory compliance of promotional activities, making adjustments as necessary to address compliance issues or regulatory concerns.
• Provide strategic input on the development and execution of promotional strategies and campaigns to ensure they align with regulatory requirements and business objectives.
• Address and resolve issues related to regulatory inspections or audits of promotional practices and materials.
• Support development of streamlined processes and best practices for promotional material review
• Collaborate with cross-functional teams, including legal, medical affairs, and commercial, to ensure cohesive and compliant messaging and documentation
• Identify and assess potential regulatory risks related to advertising, promotion, and operations, developing strategies to mitigate these risks.
• Lead investigations into regulatory issues or compliance breaches, providing actionable solutions and corrective actions as necessary.