Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)
Intellia Therapeutics, Inc.
June 26, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
How You Will Achieve More
Associate Director, Regulatory Affairs Advertising, Promotion & Labeling (AD RA-APL) provides regulatory advertising and promotion guidance for compliant external communications, partnering with commercial/launch, medical affairs, R&D, corporate communications, and legal.
Responsibilities
- Develop innovative, compliant advertising and promotion strategies.
- Advise on claims and presentations via CMLR, using FDCA and implementing regulations for advertising/promotional labeling.
- Identify risks in promotional claims and campaigns.
- Manage the FDA 2253 program, including submission of branded promotional materials to FDA APLB/OPDP at initial dissemination.
- Represent Regulatory on MRC and SCRC.
- Provide promotional regulatory input on concepts and draft materials.
- Interpret FDA regulations/guidance/enforcement letters and communicate to stakeholders for compliant commercial materials.
- Lead review/approval of materials for promotion and scientific exchange.
- Serve as primary Regulatory Advertising & Promotion contact for regulatory agencies.
- Manage contracted submission coordinator/publisher for FDA 2253.
- Maintain awareness of evolving FDA regulations, advisory/enforcement letters, and policy issues.
About You (Qualifications)
- In-depth understanding of regulatory advertising and promotional labeling.
- Track record advising on branded/unbranded promotional strategies.
- Ability to work independently and collaborate with stakeholders.
- Previous working knowledge of FDA 2253.
- 6+ years pharma/biotech; minimum 4 years as a regulatory reviewer of advertising/promotional materials.
- Demonstrated successful interactions with FDA OPDP/APLB.
- BS in scientific/clinical/related area required; advanced degree highly desirable.
- Regulatory Affairs certification a plus; product launch experience a plus.
Skills
- Exceptional medical concept understanding; strong written/oral communication and presentation skills.
- Strong technical writing, analytical/problem-solving, organization, influencing, and negotiation.
- Proficient with Microsoft Office and eTM systems (e.g., Veeva Vault PromoMats/MedComms).
- Ability to manage complex projects and escalate issues.
Applications
- Apply on a rolling basis until the position is filled.
Associate Director, Regulatory Affairs Advertising, Promotion & Labeling (AD RA-APL) provides regulatory advertising and promotion guidance for compliant external communications, partnering with commercial/launch, medical affairs, R&D, corporate communications, and legal.
Responsibilities
- Develop innovative, compliant advertising and promotion strategies.
- Advise on claims and presentations via CMLR, using FDCA and implementing regulations for advertising/promotional labeling.
- Identify risks in promotional claims and campaigns.
- Manage the FDA 2253 program, including submission of branded promotional materials to FDA APLB/OPDP at initial dissemination.
- Represent Regulatory on MRC and SCRC.
- Provide promotional regulatory input on concepts and draft materials.
- Interpret FDA regulations/guidance/enforcement letters and communicate to stakeholders for compliant commercial materials.
- Lead review/approval of materials for promotion and scientific exchange.
- Serve as primary Regulatory Advertising & Promotion contact for regulatory agencies.
- Manage contracted submission coordinator/publisher for FDA 2253.
- Maintain awareness of evolving FDA regulations, advisory/enforcement letters, and policy issues.
About You (Qualifications)
- In-depth understanding of regulatory advertising and promotional labeling.
- Track record advising on branded/unbranded promotional strategies.
- Ability to work independently and collaborate with stakeholders.
- Previous working knowledge of FDA 2253.
- 6+ years pharma/biotech; minimum 4 years as a regulatory reviewer of advertising/promotional materials.
- Demonstrated successful interactions with FDA OPDP/APLB.
- BS in scientific/clinical/related area required; advanced degree highly desirable.
- Regulatory Affairs certification a plus; product launch experience a plus.
Skills
- Exceptional medical concept understanding; strong written/oral communication and presentation skills.
- Strong technical writing, analytical/problem-solving, organization, influencing, and negotiation.
- Proficient with Microsoft Office and eTM systems (e.g., Veeva Vault PromoMats/MedComms).
- Ability to manage complex projects and escalate issues.
Applications
- Apply on a rolling basis until the position is filled.