Purpose & Scope:

The purpose of this position is to provide direction and accountability for the regulatory review of advertising and promotional materials for the Astellas portfolio of products in the US in compliance with the requirements set forth by FDA. These responsibilities apply to specific brand materials as well as certain strategic business activities. The individual will have interactions inside and outside of the Regulatory Affairs department, including with members of senior management, on complex issues, questions, regulatory policies, practices, and procedures.

Essential Job Responsibilities:

1. Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies, complex issues that influence the success and compliance of advertising and promotional labeling generated by Astellas, and relevant company materials for unapproved products/indications under development.

2. Effectively applies strong working knowledge of FDA guidance and promotion standards to business situations and medical and scientific materials content.

3. Assesses and interprets new regulatory requirements for advertising and promotion content and provides leadership for appropriate implementation strategies within Astellas. Leads Astellas teams/task forces responsible for interpretation of FDA regulations/guidelines in areas pertaining to advertising and promotion.

4. Collaborates in strategic brand planning with the US commercial organization to establish company strategies. Provides regulatory expertise and leadership for new strategic commercial initiatives, and collaborates with project teams/task forces to achieve business goals. Works closely with other individuals/groups to identify and evaluate options for risk and influence decision making.

5. Interprets clinical trial data, including health economics and outcomes, for application in commercial materials. Collaborates to provide guidance on study designs.

6. Serves as reviewer for complex promotional concepts (e.g., health systems value-added initiatives for corporate accounts) and may support review for individual brand(s) based on business need.

7. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines regarding promotion. Assists the ongoing training of key stakeholders responsible for advertising and promotion review.

8. Collaborates within Regulatory Affairs to ensure that contents of promotional and sales training materials are consistent with the current approved US Prescribing Information and provides advice regarding requirements for FDA 2253 submissions.

9. Represents Regulatory Affairs in cross-functional initiatives such as committees, training initiatives, due diligence assessments, etc.

10. Manages one or more direct reports. Recruits and hires, trains and develops Regulatory Affairs staff in advertising and promotion review and contributes to a team environment that fosters collaboration, trust, regulatory excellence and proactive initiative.

Quantitative Dimensions:

This person will interface with internal staff from the Associate to the President levels and externally with business partners and members of the FDA. The position will have direct impact on the advertising and promotional materials (hundreds annually) across Astellas brands and health systems areas in the US. The individual will impact important business goals including commercial teams' success in developing new promotional materials within established timelines for commercial business cycles and product launches. Responsibilities will also include managing Regulatory Affairs professional staff for advertising and promotion review.

Organizational Context:

Position will report to the Senior Director responsible for promotion review within US Regulatory Affairs and manage one or more direct reports at the associate director, manager or associate levels. This individual must provide organizational leadership by successfully influencing and collaborating with individuals from cross-functional teams and internal and external business partners, as well as Astellas senior management. The person will routinely collaborate in consultative discussions with regulatory and management colleagues regarding risk calibration and monitoring, in lieu of or in addition to primary role as a product reviewer. This position will support organizational initiatives within RA as well as with stakeholders external to RA.