Astellas

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:

The Associate Regulatory Advertising & Promotion Manager is 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. 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.

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 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 promotion strategies.
• Approves FDA 2253 submissions and advises 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.
• Works with supervisor direction on launch and post-launch promotion activities.

Quantitative Dimensions:

Individual has direct impact on the regulatory compliance of content and FDA submission of promotional materials developed for products marketed in the US. Individual will impact Marketing teams' success in developing new promotional materials within established timelines for commercial business cycles and product launches.

Organizational Context:

Position reports to the Director, Associate Director, or Sr. Manager Regulatory Advertising & Promotion within Regulatory Affairs. This position collaborates with various cross-functional representatives including Marketing, Legal, Medical Communications, Health Systems, and other regulatory groups. Although not a line manager, this individual is developing competency in successfully collaborate and influence individuals from other functional areas, business partners, and Astellas senior management.

Qualifications:

Required

• Bachelor's degree in scientific discipline; Advanced degree preferred.
• At least 3 years previous industry experience or PharmD or advanced degree in health sciences; 0-2 years in Regulatory Affairs or in role closely associated with interpretation of medical and scientific data.
• 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 organization.
• Proven ability to prioritize and multi-task with 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.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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Category Regulatory Affairs

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans