Regulatory Affairs Manager Jobs in Indianapolis, IN

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Champion regulatory excellence by managing complex submission strategies and stakeholder relationships to ensure timely access to diagnostics and innovative therapies globally...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Drive regulatory compliance by leading global clinical trial and marketing submissions, managing project timelines, and collaborating with scientists to ensure effective communication and adherence to...

Engage with us to drive regulatory strategies for global clinical trials and product submissions. Collaborate with scientists to ensure compliance and efficient processing while managing communication...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Transform regulatory strategies to enhance patient access to diagnostics, managing complex submissions and fostering relationships among stakeholders to navigate evolving regulations and improve outco...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Drive quality assurance for new product introductions in pharmaceuticals. Leverage leadership skills, manage cross-functional teams, and ensure regulatory compliance to deliver high-quality products e...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Empower program success by leading quality assurance, compliance, and internal audits. Drive continuous improvement initiatives and ensure all deliverables meet the highest standards in a complex fede...

Lead the charge in developing and overseeing global product labeling strategies for Neuromodulation therapies, ensuring compliance with regulatory standards, and fostering cross-functional collaborati...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

Engage in leading GCP audit programs, managing staff development, and implementing quality initiatives to enhance safety compliance. Contribute to a dynamic, science-focused environment dedicated to i...

Join a team that's passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Transform U.S. regulatory strategies in Obesity and Related Conditions, ensuring compliance and patient safety. Lead teams on global initiatives and manage key submissions for clinical trials and mark...

Transform global pharmacovigilance by leading safety assessments, managing risk, and ensuring compliance across clinical trials and regulatory submissions to enhance patient safety and product integri...

Join a dynamic team as you lead GxP compliance initiatives across global pharmaceutical operations, ensuring adherence to US-FDA regulations. Drive improvements in quality systems and prepare faciliti...

Champion regulatory excellence by leading compliance initiatives and submission strategies for in vitro diagnostics, ensuring adherence to U.S. and European regulations while partnering with cross-fun...

Lead transformative U.S. regulatory strategies for obesity therapies, ensuring compliance and collaboration with global teams to develop and execute effective plans for product registrations and lifec...