Director, Regulatory Advertising & Promotion

📋 Description

• • As the Director, Regulatory Advertising & Promotion at Sumitomo Pharma Co., Ltd., you will play a pivotal role within the Global Regulatory Affairs (GRA) team, based remotely in the US. This senior position is designed for a highly motivated and experienced professional who will serve as the primary regulatory reviewer for assigned products, ensuring all promotional and advertising materials meet stringent external regulations and internal company standards.
• • Your core responsibility will be to provide strategic, expert guidance on the advertising and promotion of assigned pharmaceutical products. This involves a delicate balance of adhering to complex regulatory requirements, such as those set forth by the FDA and PhRMA guidelines, while simultaneously supporting the business's needs and objectives to ensure commercial success.
• • You will be instrumental in developing and maintaining robust, productive working relationships with a diverse range of internal and external stakeholders. This includes close collaboration with colleagues in Marketing, Legal, Compliance, and Medical Affairs, as well as external vendors and advertising agencies. Your ability to foster these relationships will be key to the efficient development, review, and approval of promotional materials.
• • A significant aspect of this role involves providing appropriate oversight for the promotional material review process. You will be responsible for ensuring that all applicable materials are submitted to regulatory agencies accurately and on time, mitigating any potential risks associated with non-compliance.
• • You will establish and nurture a critical working relationship with the Office of Prescription Drug Promotion (OPDP) at the FDA. This involves understanding their current guidance, enforcement trends, and proactively engaging to ensure Sumitomo Pharma's promotional activities remain at the forefront of compliance.
• • Internally, you will act as the go-to regulatory expert on all FDA regulations, guidance documents, and evolving enforcement trends that govern the promotion of prescription therapies. Your insights will be crucial for informing strategy and decision-making across relevant departments.
• • The role may also encompass the responsibility for creating and reviewing Standard Operating Procedures (SOPs) and departmental operating procedures, contributing to the continuous improvement of regulatory processes and ensuring best practices are maintained.
• • You will be expected to work with a high level of autonomy, requiring minimal coaching and mentoring, and demonstrating a proactive approach to problem-solving and strategic planning.
• • This position offers the opportunity to train and mentor junior staff members, sharing your extensive expertise and fostering their development within the regulatory affairs field. You may also be tasked with overseeing the work of external consultants, ensuring their contributions align with company standards and regulatory expectations.
• • Key core competencies for this role include exceptional verbal and written communication skills, strong interpersonal abilities, active listening, and outstanding organizational skills. You must possess the ability to influence others positively and effectively, both internally and externally.
• • Unquestionable ethics, professional integrity, and personal values consistent with Sumitomo Pharma America's values are paramount. You will be expected to work effectively in a diverse environment, demonstrating the ability to prioritize tasks and manage work across different locations and time zones.
• • A demonstrated track record of successfully leading promotional copy review and approval teams, coupled with proven experience in successful interactions with OPDP staff and management, is essential.
• • You will need a strong sense of urgency and perseverance to achieve results, coupled with the capability to negotiate effectively while maintaining composure under pressure.
• • The ability to learn new therapeutic areas as needed and to make complex decisions, with a willingness to defend difficult positions, will be critical to your success.
• • Comfortably presenting to all levels of the organization, including senior management, is a required skill for this leadership position.
• • This role is integral to Sumitomo Pharma's mission of bringing novel therapies to patients by ensuring that our communication about these life-changing treatments is compliant, accurate, and effective.