Associate Director, US Regulatory Affairs- Promotional & Advertising

• Serves as internal subject matter expert on promotional and medical review committees for assigned products to ensure compliance with regulatory requirements while meeting corporate strategic promotional objectives.
• Collaborates with cross-functional teams, including Commercial, Medical, Legal, and other expertise areas for review and approval of promotional materials and materials used in scientific exchange for assigned products.
• Provides guidance and strategic support on proposed claims for products in development and develops Important Safety Information and Brief Summary documents as needed.
• Serves as primary liaison with OPDP for assigned products and manages interactions including responses to regulatory inquiries or actions, preparing high quality submissions for advisory comments, and as needed discussions.
• Educates colleagues on the regulatory environment and provides a risk assessment for proposed communication tactics and strategies.
• Continually develops, revises, and assesses best practices, working instructions, and SOPs for promotional activities to establish standards and consistency across company brands.
• Monitors for OPDP enforcement actions, new or revised legislation, regulations, guidance documents, and industry standards related to prescription drug promotion and communicates to the organization, providing training as needed.
• Works closely with Regulatory Operations in making timely 2253 submissions to OPDP.
• Works closely with Regulatory development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials.
• Provides advice regarding clinical trial design elements and labeling needed to support target product profiles and desired commercial claims.
• Helps build the USRA Advertising & Promotion team and capabilities, including support for Veeva PromoMats system updates as needed.
• Other duties as assigned.

• BA/BS degree in science or health related discipline, advanced degree preferred.
• Minimum of 7 years of regulatory affairs experience., including at least 5 years with relevant advertising and promotion review experience.
• Solid understanding of regulatory requirements, particularly in the areas of advertising and promotional activities.
• Depth of knowledge and expertise to navigate the complexities of regulatory affairs for promotional materials.
• Ability to develop and implement regulatory strategies aligned with business goals and market dynamics.
• Experience with cross-functional teams and negotiating, collaborating, and managing risk.
• Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance.
• Ability to conduct risk assessments for promotional campaigns and develop strategies to mitigate regulatory risks.
• Skilled in representing the company's regulatory interests in interactions with OPDP.
• Demonstrated ability to manage multiple assignments, appropriately identify regulatory issues and communicate as needed to management.
• Detail-oriented with the ability to promptly assess materials for accuracy as well as consistency.
• Excellent organizational skills, strong oral and written communication skills.
• Strong interpersonal skills with the ability to influence, without authority, others in a positive and effective manner.
• Managerial experience desired, but not required.

• Strong collaboration skills to work effectively with cross-functional teams, including marketing, legal, medical affairs, and regulatory teams, ensuring regulatory considerations are integrated into promotional strategies.
• Excellent communication skills, both written and verbal, to convey complex regulatory concepts clearly to various stakeholders and to represent the organization in regulatory interactions.
• Strong analytical and problem-solving skills, along with the ability to make informed decisions in a dynamic regulatory environment.
• Ability to provide training on regulatory requirements for promotional activities and support the professional development of regulatory and cross-functional teams.
• Proactively remains informed about regulatory trends, changes, and emerging requirements, and applies this intelligence to regulatory strategies.
• Flexibility and adaptability to navigate evolving regulatory landscapes and respond to changes in regulatory requirements.
• Demonstrated proficiency with Microsoft Office, Adobe Acrobat Professional (DC), and Veeva PromoMats.

• This position has significant decision-making authority.
• Ability and willingness to travel approximately 10% of the year both domestically and internationally.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Shionogi