[Hiring] Director, Regulatory Affairs, Advertising, Promotion and Labelling @Autolus Therapeutics

Role Description

The Director, Regulatory Affairs Advertising, Promotion & Labelling is responsible for leading all regulatory activities related to product labelling and the review of promotional and medical communications for Autolus products in the US/UK/EU, including providing strategic direction and tactical plans. This role requires a deep understanding of US, UK, & EU regulatory framework, exceptional strategic thinking, and the ability to navigate complex compliance requirements.

Key Responsibilities

• Develop and implement a comprehensive regulatory strategy for advertising, promotion, and medical communication activities.
• Stay abreast of FDA and OPDP/APLB regulations, guidelines, and industry trends to ensure proactive compliance.
• Lead interactions with the FDA OPDP/APLB pertinent to promotional and medical communications for assigned brand(s).
• Support the development of Promotional and Medical Communications Material Review Process.
• Advise on the development of compliant product messages and materials across multiple functional areas.
• Collaborate with Regulatory Operations to prepare and submit necessary regulatory documents (e.g. Form 2253) to OPDP/FDA.
• Collaborate closely with internal stakeholders to align on regulatory requirements and strategies.
• Foster a culture of compliance and regulatory excellence within the organization.
• Provide regulatory training as needed on FDA requirements and company materials review process.
• Lead global labelling strategy and development for assigned products.
• Serve as the global labelling subject matter expert, providing strategic guidance on regulatory requirements.
• Chair cross-functional labelling governance processes to drive timely review and approval of global labelling updates.
• Ensure global, regional, and local labelling remains aligned and compliant.
• Partner across Regulatory Affairs, Supply Chain, Manufacturing and other functions to deliver submission-ready labelling content.
• Identify and mitigate labelling risks, resolve complex labelling issues, and escalate critical matters to Regulatory Affairs leadership.
• Lead and contribute to the development of strategic responses to labelling-related Health Authority questions.
• Lead and support the creation, improvements, or periodic updates to departmental or cross-functional processes and SOPs.
• Occasional travel for business-critical meetings/events (domestic and international).

Qualifications

• BA/BS in a scientific discipline. Advanced or terminal scientific degree preferred.
• Minimum of 15 years of experience in pharmaceutical industry with at least 10 years as a Regulatory Ad Promo professional and 6 years of strategic labeling experience.
• Solid understanding of the structure and function of the product labeling.
• Strong scientific background and ability to understand and interpret scientific documents.
• Knowledge of global standards and regulations related to CCDS and Product Labeling.
• Ability to guide cross-functional labeling team.
• Self-starter with an ability to assimilate clinical and scientific information.
• Advanced understanding of FDA promotional regulations and industry trends.
• Demonstrated business acumen and understanding of company objectives.
• Proven ability to identify issues and develop risk mitigation strategies.
• Excellent communication skills (oral and written), project management, and presentation skills.
• Proficient in building agreement and acceptance through influence.
• Expert in Veeva PromoMats, and strong computer skills including MS Office.

Requirements

• Demonstrated skills and competencies in regulatory affairs and compliance.
• Ability to present a compelling case for ideas and negotiate persuasively.
• Track record of handling critical issue situations effectively.

Benefits

• Flexible, diverse, and dynamic working environment.
• Opportunities for creativity, leadership, and teamwork.

Company Description

Autolus is committed to the protection of personal information and is fully compliant with General Data Protection Regulations (GDPR). We provide an inclusive and fair workplace for all and are an equal opportunity employer.