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Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

Position Overview

The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir. RA-APL) provides regulatory advertising and promotion expertise and guidance for compliant external communications. This role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, legal and executive management to ensure external communications, including but not limited to promotional communications, are compliant with regulatory requirements and align with strategic objectives and commercial regulatory strategy. The Sr. Dir., RA-APL also provides leadership and guidance for labeling strategy and is responsible for leading cross-functional labeling sub-teams driving label development and execution.

Duties/Responsibilities

• Subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives.
• Leads Regulatory Efforts on the Promotion Review Committee (PRC) to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance. Also serves as lead Regulatory Advertising & Promotion expert on Medical Review Committee (MRC).
• Thinks innovatively and creatively, identifying the risks surrounding promotional claims and campaigns. Ability to see the impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities.
• Works consistently with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, providing advertising & promotion and labeling strategy and direction. Anticipates factors that could influence strategies and company position in the market.
• Strong working knowledge of labeling requirements to oversee development and crafting of strategic direction of the labeling component of the regulatory strategy for assigned marketed or pipeline products. Works with subject matter experts to provide strategic direction and guidance regarding new and revised labeling regulations, competitor labeling, and labeling trends.
• Advises stakeholders of key labeling considerations to ensure appropriate project and resource planning.

Requirements

• In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising & promotion expertise.
• Strong track record of implementing successful business strategies for branded and unbranded promotional campaigns.
• Successful launch experience, preferably including global product launches.
• Strong ability to work independently, with flexibility, and to collaborate with stakeholders.
• Recognized as an internal and external influential thought-leader in advertising and promotion. Evaluates, interprets, and communicates global advertising & promotion regulations and trends, including potential impact on product communications.
• Working knowledge of FDA and pharmaceutical labeling guidelines. Understanding of strategic regulatory labeling process.
• 10+ years pharmaceutical/biotech industry experience with a minimum of 8 years of direct experience as primary Regulatory reviewer of advertising and promotional materials is required.
• Proven record managing direct reports and vendors to fill gaps in subject matter expertise.
• Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch.

Education / Certifications

• BS degree in scientific, clinical or related area required. Advanced degree highly desirable.
• Regulatory Affairs Certification is a plus.

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Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement: Intellia believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.