Associate Director, Regulatory Affairs Advertising & Promotion

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 .
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.

PURPOSE AND SCOPE:

Responsible for performing regulatory review of advertising and promotional materials for Astellas in the US. Provides expertise with respect to the requirements for promotional materials as set forth by FDA. 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:

Conducts review and approval of professional and direct to consumer advertising and promotion and providing comments to review teams. Establishes effective working relationships and collaborates with cross-functional review team members representing internal functions and external business partners.
Effectively applies strong working knowledge of FDA guidance and promotion standards to business situations and medical and scientific materials content.
Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies, as well as relevant company materials for unapproved products/indications under development.
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.
Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that contents of promotional and sales training materials are consistent with the current approved US Prescribing Information and advises Regulatory Operations group regarding requirements for FDA 2253 submissions.
Advises cross-functional teams on content and message consistency and best practices regarding planning and execution.
Assures that cross-functional advertising and promotion review processes are compliant with approved company procedures.
Represents Regulatory Affairs in cross-functional initiatives such as committees, training initiatives, due diligence assessments, etc.
May manage one or more direct report. 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. Works closely with other individuals/groups to influence others to facilitate consistency, efficiency, quality and compliance and identifies options for risk discussions.