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

Intellia Therapeutics, Inc.•Cambridge, MA

20h•Remote

About The Position

The Associate Director, Regulatory Affairs Advertising, Promotion & Labeling (AD RA-APL) provides regulatory advertising and promotion guidance for compliant external communications. This role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, and legal 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. Develops innovative and compliant strategies to support advertising & promotion objectives. Represents Regulatory on the Commercial Medical, Legal, Regulatory Committee (CMLR) to navigate claims and presentations, providing advice based on the Federal Food, Drug, & Cosmetic Act (FDCA) and implementing regulations impacting advertising & promotional labeling. Thinks innovatively and creatively, identifying the risks surrounding promotional claims and campaigns. Manages the FDA 2253 program, leading submission of branded promotional materials to FDA Advertising & Promotional Labeling Branch (APLB) and/or Office of Prescription Drug Promotion (OPDP) at time of initial dissemination by Commercial. Represents Regulatory on the Medical Review Committee (MRC) and Scientific Communications Review Committee (SCRC). Experience with developing product labeling and knowledge of labeling regulations a plus.

Requirements

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.
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.
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)

Nice To Haves

Advanced degree highly desirable.
Regulatory Affairs Certification is a plus
Product launch experience is a plus

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