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 and Scope:

Responsible for performing regulatory review of advertising and promotional materials for Astellas. 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 and Material Approval process (MAP) community, as required.

Essential Job Responsibilities:

Conducts review and approval of professional and direct-to-consumer advertising and promotion and provides 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, launch strategies, and 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 consideratio

• Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that the 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 comply with approved company procedures and responsibility for creating and updating local MAP procedures such as SOPs, WPIs, and STLs as needed.

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

• Trains Material Approval Process (MAP) colleagues on regulatory affairs advertising and promotion regulations 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.

Qualifications:

Required

• Bachelor's degree in a scientificdiscipline

• At least 8 years previous industry experience; 6 years in Regulatory Affairs or in a role closely associated with the interpretation of medical and scientific data such as that associated with review of advertising and promotional materials. Scientific knowledge in chemistry, general biological/physical science, and the 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.

• 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 a high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.

• Proven track record of success with the FDA regarding advertising and promotion policy and material content.

Preferred

• Advanced degree

• Global promotional review experience

• Proven track record of working successfully through complex situations involving internal and external partners, as well as senior leadership teams.(OR) At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

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Category Oncology RA and US RA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans