Rate: Market Rates
Location: EU (Remote)
Duration: 6 months+
Position Responsibilities
- 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.