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 regulatory
interpretations 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 PromoMats system. Lead implementation of Veeva PromoMats 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 assigned.
- Occasional travel for business-critical meetings/events (domestic and international)
Demonstrated skills and competenciesE - EssentialP - PreferredExperience- 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 and concept with the ability to translate them into labeling content or in the assessment of promotional claims.
- Knowledge of global standards and regulations related to CCDS and Product Labeling (USPI and EU SmPC experience required, other regional labels also preferred)
- Ability to guide cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the assurance to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling projects
- Self-starter with an ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology
- Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product, and therapeutic knowledge as well as evidentiary standards required to support product claims.
- Demonstrated business acumen and understanding of company objectives while executing regulatory strategies that deliver compliant and timely solutions that meet business objectives.
- Proven ability to identify issues and develop risk mitigation strategies and guidance.
- Efficiently plan, prioritize, and execute individual work and projects while balancing quality, risk, and benefits.
- Excellent communication skills (oral and written), project management and presentation skills
- Ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively.
- Proficient in building agreement and acceptance through influence.
- A track-record of ability to handle critical issue situations effectively (E).
- Expert in Veeva PromoMats, and strong computer skills including MS Office: Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat
Qualifications- BA/BS in a scientific discipline. Advanced or terminal scientific degree preferred.
Autolus Leadership Behaviours (incorporating Core Competencies)Clarify direction and inspire; Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy
Deliver goals and plans; Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results
Work collaboratively; Cultivating a network of relationships across the organisation and building high performing teams based on mutual trust and respect
Optimise potential; Creating a healthy, engaged and empowered working environment that invests in people and their development.
Role Model our values; Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthrough
