Director, Regulatory Affairs, Advertising, Promotion and Labelling

Work with usOur team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.

Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Job Description:

Role Summary 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. The individual will lead and support development of collaborative processes, SOPs, and Work Instructions for cross-functional teams to ensure communications and activities are compliant and meet business objectives.

Serving as an internal subject matter expert on global labelling, Advertising & Promotion landscape, 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 Global Regulatory Promotional and Medical Communication Strategy Development:
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 and identify opportunities for optimization and innovation.

Lead interactions with the FDA OPDP/APLB pertinent to promotional and medical communications for assigned brand(s) in collaboration with the US Regulatory Lead. Provide regulatoryinterpretations of applicable guidance and/or regulations or regulatory precedents.

Support the development of Promotional and Medical Communications Material Review Process including required SOPs and Work Instructions for US (and globally based) on already established Veeva Promo Mats system. Lead implementation of Veeva Promo Mats process tools.

Advise on the development of compliant product messages and materials across multiple functional areas. Accountable for timely regulatory review and approval of US promotional and medical communications of assigned brand(s) and pipeline products. Contribute to material review meetings to ensure compliance with established processes while enabling business needs to be met efficiently and effectively. Collaborate with Regulatory Operations, prepare and submit necessary regulatory documents (e.g. Form 2253) to OPDP/FDA as related to advertising and promotion.

Collaborate closely with internal stakeholders, including Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and others as applicable to align on regulatory requirements and strategies. Provide regulatory guidance and support to cross-functional teams to ensure compliance and achieve business objectives.

Foster a culture of compliance and regulatory excellence within the organization. Foster an inclusive, collaborative, high-performing, and solution-oriented team environment to support business needs.

Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and 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 the global labelling subject matter expert, providing strategic guidance on regulatory requirements, industry trends, competitor labelling, and product impact.

Chair cross-functional labelling governance processes to drive timely review, approval, and implementation of global labelling updates.

Ensure global, regional, and local labelling remains aligned, compliant, and supported by emerging clinical, safety, and manufacturing data.

Partner across Regulatory Affairs, Supply Chain, Manufacturing and other functions to deliver submission-ready labelling content and support successful regulatory filings.

Identify and mitigate labelling risks, resolve complex labelling issues, and escalate critical matters to Regulatory Affairs leadership as appropriate.

Lead and contribute to the development of strategic responses to labelling-related Health Authority questions by partnering cross-functionally.

Lead and support the creation, improvements, or periodic updates to departmental or cross-functional processes and SOPs as…