Director, US Regulatory Affairs- Promotional & Advertising

The Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Director will have accountability for review and approval of all promotional and proactive medical materials for assigned marketed products compounds in development and disease education. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable FDA regulations guidance documents and company policies. The individual will also serve as the primary liaison for leading interactions with the Office of Prescription Drug Promotion (OPDP) for assigned products. Additionally the Director will help build the USRA Advertising & Promotion team and capabilities and may be responsible for supervising or mentoring other team members and fostering their development. This position will report to the Senior Director USRC Advertising & Promotion.

The Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Director will have accountability for review and approval of all promotional and proactive medical materials for assigned marketed products compounds in development and disease education. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable FDA regulations guidance documents and company policies. The individual will also serve as the primary liaison for leading interactions with the Office of Prescription Drug Promotion (OPDP) for assigned products. Additionally the Director will help build the USRA Advertising & Promotion team and capabilities and may be responsible for supervising or mentoring other team members and fostering their development. This position will report to the Senior Director USRC Advertising & Promotion.

Responsibilities

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 crossfunctional 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.

Minimum Job Requirements

Qualifications

BA/BS degree in science or health related discipline advanced degree preferred.

Minimum of 10 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 crossfunctional 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 companys regulatory interests in interactions with OPDP.

Demonstrated ability to manage multiple assignments appropriately identify regulatory issues and communicate as needed to management.

Detailoriented 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.

Competencies

Strong collaboration skills to work effectively with crossfunctional 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 problemsolving 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 crossfunctional 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.

Other Requirements

This position has significant decisionmaking 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

Essential Physical and Mental Requirements

Ability to travel via automobile and/or airplane.

Ability to view video display terminal images < 18 away from face for extended period of time up to four (4) hours at a time.

Ability to operate a computer keyboard and telephone.

Ability to sit for extended periods of time up to four (4) hours at a time.

Ability to lift tug pull up to fifteen (15) pounds.

To be considered for this position you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements duties or responsibilities that are required of the employee. Other requirements duties and responsibilities may change or be assigned at any time with or without notice.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities alliance partners and/or thirdparty service providers as necessary for Shionogi to fulfil its obligations under applicable laws including but not limited to compliance with regulatory inspections and/or audits.

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact nondiscriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by callingor by sending an email to