Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Regulatory Advertising/Promotion Manageropportunity in Northbrook, IL.
Purpose & Scope:
Responsible for performing regulatory review of advertising and promotional materials. Provides expertise with respect to the requirements for promotional materials as set forth by FDA. Develops and maintains a positive working relationship with regulatory colleagues from business partners. Advises teams on best practices regarding planning and execution of marketing strategies. Assures that cross-functional advertising and promotion review teams are operating according to approved company processes. Responsible for the training of regulatory staff, as required.
Essential Job Responsibilities:
1. Provides regulatory guidance regarding advertising and promotional materials, new campaigns, and launch strategies 2. Conducts review and approval of professional and direct to consumer advertising and promotion and providing comments to review teams 3. Establishes strong working relationships with cross-functional review team members, both internal and with co-promotional partners 4. Possesses working knowledge of FDA guidance and applies understanding to business situations 5. Makes and executes challenging decisions based upon sound regulatory knowledge, but also understands when a decision should be elevated to upper management for further consideration 6. Advises cross-functional teams on content and message consistency and best practices regarding planning and execution 7. Advises Regulatory Operations group regarding special requirements for FDA 2253 submissions 8. Works closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate
Individual will impact Marketing teams' success in developing new promotional materials within established timelines for commercial business cycles and product launches. Individual also has direct impact on the regulatory compliance of promotional materials.
Position will report to a Director or Senior Director of Advertising/Promotion Review within Regulatory Affairs. Although not a direct manager, this individual must successfully influence and collaborate with individuals from cross-functional teams and business partners, as well as Astellas senior management.
Bachelor's degree in scientific discipline
At least 7 years previous industry experience; 4 in Regulatory Affairs or in a role closely associated with interpretation of medical and scientific data such as that associated with review of advertising and promotional material. Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
Direct advertising and promotional material review experience required.
Able to communicate effectively and maintain effective working relationships. Must be able to effectively influence peers and others within the organization.
Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships.
Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
Astellas Pharma US, Inc. is committed to providing patients, customers, community and employees with a bright future by Changing Tomorrow. Our commitment is made possible because we are a different kind of pharmaceutical company. This is apparent not only in what we do, but how we do it.