Associate Director, Regulatory Affairs, US/Canada

Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific,...

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

As a Director Wellbeing & Regulatory Affairs (Salty, Portable Wholesome Snacks & Customer Activation), you will drive differentiation and enable share growth. This will be achieved by providing strategic wellbeing & regulatory thought leadership to K Regulatory Affairs, Director, Regulatory, Communications, Manufacturing, Business Services, Business

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements. Main Responsibilities Lead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements. While professional experience and qualifications are key for...

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

Job Description The Associate Director, Regulatory Affairs, Strategic Global Labeling – Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation. This individual has influence within the department...

Accountability / Scope:As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions...

**Company Description** The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx global...

Job Description: Medical Director, Medical Affairs Overview: Join our client's team as a Medical Director, Medical Affairs, where you will provide medical, scientific, strategic, and operational leadership. You will play a key role in activities such as generating clinical and scientific data, enhancing therapeutic benefit, ensuring safety and value,...

Job Description: Medical Director, Medical AffairsOverview: Join our client's team as a Medical Director, Medical Affairs, where you will provide medical, scientific, strategic, and operational leadership. You will play a key role in activities such as generating clinical and scientific data, enhancing therapeutic benefit, ensuring safety and value,...

Job Description Take the next step in your career with an organization that strategically invests in the long-term health of the company, its technology and its people. The AbbVie Business Technology Solutions (BTS) team shapes the digital transformation necessary for our treatments to positively impact patients’ lives.  Join our collaborative and global...

**About the Department*** The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...

Job Description   Senior Manager Medical Affairs Quality Assurance is responsible for providing independent quality oversight of GxP activities executed by AbbVie’s Medical Affairs enterprise, including but not limited to non-interventional studies, medical information and other regulatory commitments., covering the AbbVie drug, device and cosmetic...

Job Title: Regulatory SpecialistDuration: 6 months (Potential extension)Location: Hybrid - Chicago, IL 60642SummaryAs a member of the Scientific & Regulatory Affairs (SRA) team, this role focuses on screening, tracking, and managing regulatory information related to ingredients. Ensuring the accuracy and completeness of ingredient data is crucial for...

Job Title: Regulatory Specialist Duration: 6 months (Potential extension) Location: Hybrid - Chicago, IL 60642 Summary As a member of the Scientific & Regulatory Affairs (SRA) team, this role focuses on screening, tracking, and managing regulatory information related to ingredients. Ensuring the accuracy and completeness of ingredient data is crucial for...