[Hiring] Director, Regulatory Advertising & Promotion @Sumitomo Pharma America, Inc.

Role Description

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Regulatory Advertising & Promotion. The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible for providing strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives.

• Review and approve materials that comply with relevant external advertising & promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding principles.
• Align with regulatory colleagues on strategies to optimize the commercial success of products for clinical trials, labeling, etc.
• Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of promotional materials, e.g. Marketing and their Agencies, Legal, Compliance, and Medical Affairs.
• Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applicable materials to regulatory agencies.
• Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA.
• Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription therapies.
• May be responsible for creating and reviewing SOPs and department operating procedures.

Qualifications

• 8 – 12 years experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory advertising & promotion.
• Advanced degree preferred (preferably in a scientific discipline).

Requirements

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills with the ability to influence others, internally and externally, in a positive and effective manner.
• Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values.
• Ability to work in a diverse environment.
• Ability to prioritize tasks and work across locations and time zones.
• Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization.
• Demonstrated track record of leading promotional copy review and approval team and of successful interactions with OPDP staff and management.
• Sense of urgency and perseverance to achieve results.
• Capable of effectively negotiating with others while maintaining composure.
• Ability to learn new therapeutic areas when necessary.
• Ability to make complex decisions and willingness to defend difficult positions.
• Comfortable presenting to all levels of the organization including Senior Management.

Benefits

• The base salary range for this role is $187,520 to $234,400.
• Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.
• Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.