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.
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 & 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 liason 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.
The position will have direct impact on the advertising and promotional materials (hundreds annually) across assigned brands in the oncology therapeutic areas in the US. Thus, 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. The position has impact on regulatory compliance of commercialized products in the Americas as well as some activities associated with non-promotional external communications in the US for projects in development.
Position will report to a Sr. Director or Director of Promotion Review within US Regulatory Affairs and may manage one or more direct reports at the manager or associate levels. This individual must successfully influence and collaborate with individuals from cross-functional teams and internal and external business partners, as well as Astellas senior management. Routinely collaborates with regulatory colleagues and management in other groups including Marketing, Marketing Operations, and other commercial groups, Medical Affairs, Legal, Corporate Compliance and global development and business functions.
Bachelor's degree in a scientific discipline.
At least 9 years previous industry experience; 6 years 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 simultaneous.
Prior experience with Oncology
Proven track record of working successfully through complex situations involving internal and external partners, as well as senior leadership teams.
Category Global Labeling & Regulatory Intelligence
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans