The Premier Resource for All Your Professional Needs

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.

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.

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. 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.

Essential Job Responsibilities:

• Provides regulatory guidance regarding advertising and promotional materials, campaigns, launch strategies, and campaign strategies
• Conducts review and approval of professional and direct to consumer advertising and promotion and providing 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 Regulatory Operations group regarding special requirements for FDA 2253 submissions
• Works closely with RA labeling group regarding package insert changes to assure that PI and important safety information are updated as appropriate
• Assures that cross-functional advertising and promotion review processes are compliant with approved company procedures
• Works with supervisor direction on launch and post-launch promotion activities

Quantitative Dimensions:

Individual has direct impact on advertising and promotional materials across assigned brands across 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. Individual also has direct impact on the regulatory compliance of promotional materials in the Americas as well as some activities associated with non-promotional external communications in the US for projects in development.

Organizational Context:

Position will report to a Director or Associate Director of Advertising/Promotion Review within US Regulatory Affairs. This position routinely collaborates with regulatory colleagues and various cross-functional representatives including Marketing, Commercial Operations, Medical Communications, Health Systems, Legal and Corporate compliance. Although not a line manager, this individual is developing competency in successfully influence and collaboration with individuals from cross-functional teams and business partners, as well as Astellas senior management.

Requirements: 

Qualifications:

Required:

• Bachelor's degree in scientific discipline; Advanced degree preferred
• At least 5 years previous industry experience, with 3 in Regulatory Affairs or relevant experience in a role closely associated with interpretation of medical and scientific data such as that associated with review of advertising and promotional material; or PharmD or advanced degree in health sciences and 3 years in RA or relevant experience in a role associated with medical and scientific data interpretation such as promotional materials.
• 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 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
• #LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled.