/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide

Assist in the preparation of external reports, ESG disclosures, and surveys such as CDP, EcoVadis, S&P Global and others. Assist in the collection, analysis and management of data for ESG reporting frameworks and support work processes, policies, etc. Collaborate with various teams to address customer inquiries and requests related to ESG topics. Proactively identify oppo

The Policy Advisor is a key member of the policy team, reporting directly to the Policy Director. This role involves providing strategic advice, conducting in depth policy analysis, and assisting in the development and implementation of policies, initiatives, and strategic priorities for Montgomery County. The Policy Advisor plays a critical role in supporting decision ma

. Work Schedule and Additional Information Full time employment, 37.5 hours per week Work hours are 8 30 AM to 5 00 PM, Monday Friday, with 60 minute lunch. The DHS provides excellent benefits, contractual pay increases, paid holidays and leave entitlements, opportunity for advancement and shift selection in addition to a great work environment. Travel and overtime as nee

. Work Schedule and Additional Information Full time employment Work hours are 8 30 AM to 5 00 PM, Monday Friday, with a 60 minute lunch. May change based on operational needs. Travel and overtime As needed Shift work No Assigned duties are performed in a controlled office environment. In counties with district offices, employees may be reassigned to different work sites

. Work Schedule and Additional Information Full time employment, 37.5 hour work week Work hours are 8 30 AM to 5 00 PM, Monday to Friday, with 60 minute lunch. May change based on operational needs. The Department of Human Services provides excellent benefits, contractual pay increases, paid holidays and leave entitlements, opportunity for advancement and shift selection

PRIMARY FUNCTION The Associate Regional Compliance Officer (ARCO), Thomas Jefferson University ndash; Center City, will be responsible for assisting the Regional Compliance Officer (RCO) in the oversight of all activities, functions, and initiatives related to the development, implementation, oversight, and maintenance of the Corporate Compliance and Ethics Program, which

. Work Schedule and Additional Information Full time employment, 37.5 hour work week Work hours are 8 30 AM to 5 00 PM, Monday Friday, with 60 minute lunch. May change based on operational needs. This position is not eligible for telework. The DHS provides excellent benefits, contractual pay increases, paid holidays and leave entitlements, opportunity for advancement and

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

. Work Schedule and Additional Information Full time employment Work hours are 8 30 AM to 5 00 PM, Monday Friday, with a 60 minute lunch. May change based on operational needs. Travel and overtime as needed Shift work No Free Parking! Assigned duties are performed in a controlled office environment. In counties with district offices, employees may be reassigned to differe

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor