Associate Director, Regulatory Affairs Advertising & Promotion
Astellas Pharma
- Northbrook, IL
- Permanent
- Full-time
- 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.
- 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.
- Bachelor’s or advanced degree in a health science
- Advanced degree
- Proven track record of working successfully through complex situations involving internal and external partners, as well as senior leadership teams.
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
- 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