Director, Regulatory Affairs Jobs in Indianapolis, IN

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

Unlock potential by managing complex regulatory projects, ensuring quality deliverables, and leading cross-functional initiatives. Utilize your expertise to provide strategic consultancy and complianc...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Join us in driving operational excellence in regulatory submissions and document workflows. Lead cross-functional teams to ensure compliance and quality across all submissions while optimizing process...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Contribute to regulatory leadership in post-approval CMC activities, overseeing global strategies for timely execution of changes in parenteral products. Leverage technical expertise and collaboration...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Join a team that's shaping the future of regulatory communications. Lead initiatives to ensure compliant promotional strategies for FDA interactions, fostering collaboration across diverse teams to dr...

Shape the future of impactful product communications by leading regulatory strategies, enabling compliant tactics, and influencing partnerships within dynamic brand teams to ensure effective, substant...

Drive global regulatory strategy and empower teams to ensure timely product registrations, enhancing access to innovative diagnostic solutions. Collaborate with leadership to shape impactful strategie...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...