[Remote] Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)

Note: The job is a remote job and is open to candidates in USA. Intellia Therapeutics, Inc. is dedicated to developing curative genome editing treatments for severe diseases. The Associate Director will provide regulatory guidance for advertising and promotion, ensuring compliance with regulations while collaborating with various teams to align communications with strategic objectives.

Responsibilities

• Interprets content of FDA regulations, guidance documents, and enforcement letters and communicates information to stakeholders in order to ensure compliant commercial materials
• Accountable for review and approval of materials for both promotion and scientific exchange, in line with relevant goals and deliverables with a broad impact on the organization
• Proposes creative, effective and compliant regulatory strategies and solutions to promotional concepts that meet business objectives and minimize risk
• Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives
• Primary Regulatory Advertising & Promotion contact for Regulatory Agencies
• Manages contracted submission coordinator and publisher related to FDA 2253 program
• Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry
• Solid understanding of pharmaceutical regulatory affairs, and knowledge of fundamentals of labeling regulatory requirements and industry practice
• Exceptional understanding of medical concepts and terminology, and strong written and oral communication skills, including presentation skills
• Strong aptitude for use of electronic systems to support Regulatory reviews and submissions

Skills

• In-depth understanding of regulatory advertising and promotional labeling concepts
• Consistent track record of advising on successful business strategies for branded and unbranded promotional campaigns
• Strong ability to work independently, with flexibility, and to collaborate with stakeholders
• Previous working knowledge of FDA 2253 program
• Experience in managing complex projects. Demonstrated ability to work with people in a global, dynamic environment to deliver value-added results. Solid ability to recognize and escalate issues. Capable of dealing with ambiguity. Creative and comfortable working with multifunctional teams
• Strong interpersonal skills. Proven negotiator and demonstrated ability to use constructive debate to identify and move others towards compliant promotional outcomes
• 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, and electronic document management systems (e.g., Veeva Vault PromoMats and MedComms)
• BS degree in scientific, clinical or related area required. Advanced degree highly desirable
• 6+ years pharmaceutical/biotech industry experience with a minimum of 4 years of direct experience as Regulatory reviewer of advertising and promotional materials is required
• Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB)
• Solid understanding of pharmaceutical regulatory affairs, and knowledge of fundamentals of labeling regulatory requirements and industry practice
• Exceptional understanding of medical concepts and terminology, and strong written and oral communication skills, including presentation skills
• Strong aptitude for use of electronic systems to support Regulatory reviews and submissions
• Experience with developing product labeling and knowledge of labeling regulations a plus
• Product launch experience is a plus
• Regulatory Affairs Certification is a plus

Benefits

• Additional compensation includes a performance-based annual cash bonus
• A new hire equity grant
• Eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion

Company Overview

• Intellia Therapeutics is a leading clinical-stage biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. It was founded in 2014, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://intelliatx.com.

Company H1B Sponsorship

• Intellia Therapeutics, Inc. has a track record of offering H1B sponsorships, with 1 in 2026, 13 in 2025, 38 in 2024, 63 in 2023, 46 in 2022, 10 in 2021, 6 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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