9 jobs found in Fort Smith, AR

This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron’s data maturity roadmap including policies & procedures.   They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization.   They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices. In this role, a typical day might include the following: The creation & delivery of IOPS’ DG Program (Strategy,...

CORE RESPONSIBILITIES Formulate and execute a high-impact sales strategy for increased placements of the Robotic System, collaborating with senior leadership and providing strategic content for sales meetings. Partner with the Senior Director of Sales to establish metrics for monitoring and enhancing sales performance, emphasizing sustainable growth through targeted resource deployment. Drive field activities to expand placements, manage resources effectively, and cultivate key relationships within facilities to establish strong corporate partnerships. Lead achievement of sales goals by providing clinical expertise, contributing to the enhancement of Company's marketplace reputation. Provide regular updates on competition, product use, clinical updates, and key business metrics to the Senior Director of Sales. Conduct frequent field visits to support sales execution, facilitate team professional development, and deliver compelling executive presentations to...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics is...

Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:   Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems Leading proactive evaluation and education of site GMP compliance against current and emerging...

The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning. Essential Duties and Responsibilities include, but are not limited to, the following: Leading and the management of the process equipment engineering, maintenance, and calibration teams.  Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement. Owning the introduction of new process...

The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry, manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. In this role, you will be encouraged to develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across Regeneron. A typical day might include, but is not limited to, the following:   Providing oversight on the IOPS CMC intelligence program Collaborating with the Regulatory Intelligence and GMP Compliance & Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS Monitoring and assessing all sources of...

The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Amsterdam office. The role is positioned at the Associate Director level to enable independent working and leadership in direct interactions with EU Regulatory agencies and with our business partners. This role will be focused on supporting development activities and developing teams in the area of cardiovascular, metabolic and allergic diseases. What a typical day might look like; Lead, handle and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team. Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required. Assist Development teams in developing strategies that...

The Director/Sr Director EHS & Security will be responsible for the oversight of all Health, Safety, Environmental and Security operations to comply with or exceed local and national environmental regulatory compliance for IOPS (Industrial Operations & Product Supply) division of Regeneron in Limerick. As the Director/Sr Director EHS & Security, a typical day might include, but is not limited to, the following: Driving safety culture, programs, and behavioral awareness Developing policy, programs, direction and coordinating the activity of the Environmental, Health and Safety (EHS) and Security teams Reporting EHS and Security metrics to the Senior Leadership Team Driving organizational development and changes Ensuring emergency planning and risk management occurs for sites Reviewing and revising compliance documents pertaining to EHS and security issues including SOP’s, plans and policies routinely and as needed Directing, reviewing and...

Your role is fundamental in ensuring Regeneron’s data is effectively managed and utilised whilst remaining compliant with regulatory requirements. You will play a key role in fostering a data compliance culture and being a ccountable for developing comprehensive Data Governance (DG) policies a nd procedures across the organization. You will m onitor the adoption of these policies and stay abreast of industry trends, technology advancements and external compliance decisions . Your remit will include s upporting internal data audits, ensuring inspection readiness and governance related to IOPS related acquisitions.     In this role, a typical day might include the following: Generation of policies and procedures based on current and evolving global standards, ensuring global IOPS alignment and adjusting established policies and practices Responsible with Site Leads f or the creation...