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Associate Director, Regulatory Affairs Advertising
4 months ago
**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. 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 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.
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.
**Quantitative Dimensions**:
The position will have direct impact on the advertising and promotional materials (hundreds annually) across assigned brands in the ophthalmology 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.
**Organizational Context**:
Position will report to a Sr Director or Director of Promotion Review within US Regulatory Affairs. 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.
**Qualifications**:
**Required**
Bachelor's degree in a scientific discipline.
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 mínimal 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.
**Preferred**
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.
**Benefits**:
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 C
