Director of Regulatory Affairs, CMC

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

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...

Job Description   Manages multiple projects and contributes to project prioritization. Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving joint decisions for the development programs. Key member of Asset Strategy Team (AST) and ensures CMC strategy is...

Job Description Opportunity at a Glance The Senior Regulatory Affairs Analyst is responsible for interpreting statutes, regulations and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those rules and monitoring the performance of those procedures and processes. The senior analyst will serve...

Job Description   Leads several early stage and/or LCM projects utilizing matrix management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy.  Lead DevSci cross-functional initiatives and strategies.   From GLP tox through IND towards clinical PoC and...

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...

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...

Job Description Opportunity at a Glance The Senior Regulatory Affairs Analyst is responsible for interpreting statutes, regulations and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those rules and monitoring the performance of those procedures and processes. The senior analyst will serve...

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,...

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...

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...

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...

Position Overview The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...

**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 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...

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...

Communicates with the CCTO study teams and disease programs distributing new NCTN study activations, closures, termination, amendments and safety reports, etc. - Processes IRB, submissions to include but not limited to annual reviews and Adverse Even Regulatory, Coordinator, Clinical, Audit, Regulatory Affairs, Project Management, Business Services

Job Description Job Description Job Title: Regulatory SpecialistDuration: 6 months (Potential extension)Location: Hybrid - Chicago, IL 60642Summary: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...

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...