Director, Regulatory Affairs – Advertising, Promotion and Labelling

Autolus Therapeutics

. Develop and implement regulatory strategies for advertising, promotion, and medical communications .

Posted 10/8/2026full-timeRemote • New Jersey • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory strategies for advertising and promotion within the pharmaceutical industry, with a strong focus on labelling compliance and FDA regulations. Proven ability to lead cross-functional teams and manage complex regulatory processes effectively.

Highest-signal resume keywords

Regulatory Advertising And PromotionStrategic Labelling ExperienceVeeva PromoMats ExpertiseFDA Promotional RegulationsUSPI And EU SmPC Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentMaterial Review ProcessRegulatory Document PreparationLabelling Risk MitigationScientific Document Interpretation

Soft Skills

Excellent Communication SkillsProject ManagementPersuasive NegotiationProblem-SolvingCross-Functional Collaboration

Tools & Technologies

Veeva PromoMatsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookMicrosoft TeamsAdobe Acrobat

Industry Keywords

Pharmaceutical IndustryRegulatory ComplianceFDAPhRMA DTC GuidelinesProduct LabellingCCDSTPLsSmPCUSPIHealth Authority

About the role

Key responsibilities & impact

Develop and implement regulatory strategies for advertising, promotion, and medical communications
Lead interactions with FDA OPDP/APLB regarding promotional and medical communications
Interpret applicable regulatory guidance, regulations, and precedents
Support and implement the Promotional and Medical Communications Material Review Process using Veeva PromoMats
Advise on compliant product messages and materials across functional areas
Lead timely regulatory review and approval of US promotional and medical communications
Contribute to material review meetings
Prepare and submit regulatory documents, including Form 2253, to OPDP/FDA
Collaborate with Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and other stakeholders
Foster regulatory compliance and excellence
Provide training on FDA requirements, PhRMA DTC Guidelines, and the company materials review process
Lead global labelling strategy and development for assigned products, including TPLs, CCDS, USPI, SmPC, and related core labelling documents
Serve as global labelling subject matter expert
Chair cross-functional labelling governance processes
Ensure global, regional, and local labelling remains aligned and compliant with clinical, safety, and manufacturing data
Partner with Regulatory Affairs, Supply Chain, Manufacturing, and other functions on submission-ready labelling and regulatory filings
Identify and mitigate labelling risks and resolve complex labelling issues
Develop strategic responses to labelling-related Health Authority questions
Create, improve, and update departmental or cross-functional processes and SOPs
Attend occasional domestic and international business-critical meetings/events

Requirements

What you’ll need

Minimum of 15 years of experience in the pharmaceutical industry
At least 10 years as a Regulatory Advertising and Promotion professional
At least 6 years of strategic labelling experience
Solid understanding of the structure and function of product labelling
Strong scientific background and ability to interpret scientific documents and concepts
Knowledge of global standards and regulations related to CCDS and product labelling
USPI and EU SmPC experience required
Ability to guide cross-functional labelling teams, including senior management
Understanding of medical concepts and terminology
Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, products, therapeutic knowledge, and evidentiary standards for product claims
Demonstrated business acumen and understanding of company objectives
Proven ability to identify issues and develop risk mitigation strategies
Excellent oral and written communication, project management, and presentation skills
Ability to negotiate persuasively and address disagreements constructively
Track record of handling critical issue situations effectively
Expert in Veeva PromoMats
Strong computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat
BA/BS in a scientific discipline
Must be based in US-New Jersey (Remote)

Benefits

Comp & perks

Flexible, diverse and dynamic working environment
Inclusive and fair workplace
Reasonable accommodations throughout the recruitment process
Professional development and investment in people
Occasional domestic and international business travel opportunities