Manager, Regulatory Affairs

Role: Regulatory Affairs Specialist supporting global regulatory projects for Arrowhead's RNAi-based therapeutics, focusing on compliance, regulatory strategy development, and submission management. Responsibilities: lead preparation and submission of INDs, CTAs, annual reports, and briefing documents; develop and execute regulatory plans aligned with product development and commercialization; coordinate interactions with health authorities and collaborate with global/regional regulatory teams for marketing applications; create project plans, monitor timelines, and ensure regulatory compliance across development activities; review technical documents for regulatory adherence; stay current on regulatory guidelines and communicate updates internally. Requirements: Bachelor’s or Master’s degree with at least 5 years (or PhD/PharmD with 3+ years) in regulatory affairs, deep knowledge of FDA and international regulations; proven project management skills in a cross-functional environment; excellent communication and negotiation abilities; detail-oriented and adaptable to fast-paced, entrepreneurial settings. HighValue: regulatory strategy and submissions for biologics, gene therapies, or RNAi-based drugs; experience with IND/CTA, global marketing applications, and interactions with health authorities. WorkSetup: not specified.