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Director, Regulatory Affairs Promotional and

3 weeks ago

East Coast, Singapore Autolus Ltd Full time

**Location**:

- United States, East CoastKey Responsibilities
- 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.
- Support the creation, improvements, or periodic updates to departmental or crossfunctional processes and SOPs as assigned.
- Occasional travel for business-critical meetings/events (domestic and international)