Sr Director, Regulatory Affairs Advertising, Promotion & Labeling Job at Intelli

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.

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.

• 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 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 who can 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.
• Advise stakeholders of key labeling considerations to ensure appropriate project and resource planning

Duties/Responsibilities

• Interprets and implements FDA Guidance. Has deep understanding of business strategies
• Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution
• Proposes creative, effective and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk.
• Support Commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives.
• Leads the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission, where applicable, of external communications content
• Acts as the recognized authority on regulatory advertising and promotion matters and requires little, if any, supervision dealing with division or corporate functions, or with external agencies.
• Interfaces with all levels of corporate management and multiple functions. Primary Regulatory Advertising & Promotion contact for Regulatory Agencies.
• Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US promotion.
• Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders.
• Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review
• Oversees preparation, review, and update of content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), local labeling and labeling components. This also includes evaluation and communication of risks associated with CCDS content updates and implementation strategies. Supports global HA interaction strategy to discuss key labeling elements
• Demonstrates high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
• Working closely with Global Regulatory Lead (GRL) and external experts, continuously assesses dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.

• Ensures policies and practices are maintained so that local labels are consistent with global labeling. Contributes to, develops & implements solutions to build awareness of early labeling development and global strategic mindset.
• Solid understanding of pharmaceutical regulatory affairs, and knowledge of fundamentals of global labeling regulatory requirements and industry practice. Exceptional understanding of medical concepts and terminology, and strong written and oral communication skills, including presentation skills. In addition, strong aptitude for use of systems to support Regulatory submissions (RIMS, Veeva, electronic document management systems, etc.)

Supervisory Responsibilities

N/A

• Recruits, interviews, hires, and trains new staff. Oversees Consultants to provide subject matter expertise where gaps are identified.
• Oversees the daily workflow of the department.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employees in accordance with company policy.

Requirements

Skills/Abilities

• 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. Evaluate, interpret, and communicate 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.
• Demonstrated ability to hire and manage FTE/Consultant/Strategy support to provide labeling expertise to Regulatory and Product Labeling Team (PLT) for assigned products regarding language, placement and regulatory content detail for core prescribing information in line with procedures, regional labeling regulations, and guidance.
• Considerable experience in managing high to medium complex projects. Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results. Strong established personnel development skills. Proven matrix leader with excellent problem-solving innovative solutions. Demonstrated ability to provide leadership and development for junior team members. Solid ability to recognize and escalate issues. Able to build effective teams and capable of dealing with ambiguity. Must be creative and comfortable working with multifunctional teams and show strong business acumen.
• Builds team with individuals who have the right skills and experience to deliver on organizational goals. Demonstrates leadership presence and confidence. Models these behaviors for the organization.
• Motivational presenter
• Strong interpersonal skills. Proven negotiator and demonstrated ability to use constructive debate to identify and move others towards compliant promotional outcomes.
• Defines training programs
• Well organized with exceptional communication skills, strong influencing skills, strong technical writing and documentation skills, as well as strong analytical and problem-solving skills.
• Proficient in computer applications and configurations including Microsoft Office Suite or related software, Veeva PromoMats and Veeva MedComms systems.

Education / Certifications

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

Experience

• 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

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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.