Regulatory Affairs Specialist Jobs in Indianapolis, IN

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Shape a quality control framework for cancer registrars by conducting audits, providing essential feedback, and ensuring compliance with standards. Collaborate with a dedicated team to enhance data qu...

Champion effective environmental compliance practices by assessing and addressing federal and state regulations in manufacturing. Blend fieldwork with documentation to ensure sustainable operations an...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Elevate clinical outcomes by serving as the key pharmacist liaison among partners, translating real-world issues into actionable insights, driving resolution of clinical concerns, and enhancing produc...

Drive impactful medical communication strategies by crafting precise scientific content and collaborating with cross-functional teams to meet diverse client needs within a dynamic healthcare landscape...

Optimize quality systems for finished products, ensuring compliance with FDA and EMA standards. Collaborate cross-functionally to enhance inspection, labeling, and packaging processes while maintainin...

Lead the charge in the inspection operations of a dynamic biopharma company. Drive strategic initiatives, ensure compliance, and develop talent while managing multiple shifts in a fast-paced, quality...

Join a team that's shaping healthcare through innovative legal counsel. You'll oversee commercial contracting, guide compliance, and streamline legal operations for critical partnerships in health sys...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Drive quality and compliance by analyzing incoming GMP materials, conducting inspections, and collaborating with cross-functional teams to ensure adherence to regulatory standards. Mentor staff in bes...

Join a team that's dedicated to maintaining Good Clinical Practice and human subject protection. Oversee site monitoring, ensure compliance, and support clinical studies through effective communicatio...

Engage in pivotal clinical trial monitoring, ensuring compliance and protecting participant rights while collaborating with investigators and coordinating site activities throughout the research proce...

Champion a comprehensive GVP quality program, partnering with multiple departments to ensure compliance through audits, training, and continuous improvement initiatives. Your expertise will enhance op...

Help us drive product success in biopharma by managing lifecycle initiatives, collaborating cross-functionally, and supporting growth strategies to enhance profitability and customer satisfaction acro...

Explore opportunities as a Clinical & Regulatory Information Management SME, supporting client delivery across VeevaRIM and Clinical initiatives. Engage with stakeholders, optimize processes, and enha...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...

Drive quality assurance in GMP operations, ensuring compliance and product integrity while collaborating with internal and external stakeholders. Contribute to clinical manufacturing excellence throug...

Help us shape the future of clinical trials by providing regulatory guidance and maintaining compliance. Collaborate within cross-functional teams to ensure successful submissions and uphold industry...

Unlock potential in regulatory affairs by steering clinical trial submissions, ensuring compliance and strategic oversight. Collaborate with project teams, advising on regulatory pathways for successf...