Regulatory Affairs Advertising & Promotion, Manager
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at www.astellas.com .
Purpose :
Responsible for performing regulatory reviews of advertising and promotional materials for Astellas in the US. Provides expertise concerning 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 .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.
Essential Job Responsibilities :
- Provides regulatory guidance regarding advertising and promotional materials, new campaigns, and launch strategies.
- Conducts review and approval of professional and direct-to-consumer advertising and promotion and provides comments to review teams.
- Establishes strong working relationships with cross-functional review team members, both internal and with co-promotional partners
- Possesses working knowledge of FDA guidance and applies understanding to business situations.
- 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.
- Advises cross-functional teams on content and message consistency and best practices regarding planning and execution of promotional strategies.
- Approves FDA 2253 submissions and advises the Regulatory Operations group regarding special requirements for FDA 2253 submissions.
- Works closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate .
- Assures that cross-functional advertising and promotion review processes are compliant with approved company procedures.
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