- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Regulatory Project Manager (Department of Neurology) Job Profile Title ... In collaboration with Principal Investigators and the FTDC Clinical Research Program Director, the Regulatory Project Manager will take a leadership role in… more
- LA Care Health Plan (Los Angeles, CA)
- Regulatory Operations Project Manager II Job Category: Administrative, HR, Business Professionals Department: Compliance Location: Los Angeles, CA, US, 90017 ... net required to achieve that purpose. Job Summary The Regulatory Operations Project Manager II...and provide timely, accurate status reports. Ensure the timely submission of the executive summaries to the Compliance Leadership… more
- Dignity Health (Phoenix, AZ)
- …growth opportunities? Join the Barrow Neurological Research Team as a Clinical Research Regulatory Project Manager !** **This position will be responsible for ... follow us on Twitter (https://twitter.com/DignityHealthAZ) . **Responsibilities** The Clinical Research Regulatory Project Manager position exists to support… more
- West Pharmaceutical Services (Exton, PA)
- …latest guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs ... Sr. Specialist, Regulatory Project Mgmt Requisition ID: 66496...(RA) team's priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Manager , Regulatory Promotional Operations, is a subject matter expert specializing ... project through the various stages of the MLR review process. The Manager provides expert guidance on submission timelines and resource requirements to… more
- Publicis Groupe (New York, NY)
- …stability and experience of a global leader. **Job Description** The Senior Manager , Regulatory Promotional Operations, is a subject matter expert specializing ... ensure a seamless MLR review process from start to finish. The Senior Manager provides expert guidance on submission timelines and resource requirements,… more
- Publicis Groupe (New York, NY)
- …trades, or just an all-around nice person, let's chat. **Job Description** The Manager , Regulatory Review is responsible for ensuring regulatory submissions ... for promotional materials. This includes managing components of a submission package based on project type, experience...Account teams as they prepare projects for Medical Legal Regulatory (MLR) review + Submit completed materials to the… more
- ICU Medical (UT)
- …guidance when necessary. Review technical reports and determine acceptability for regulatory submission . * Identify registration documentation deficiencies, work ... Position Summary The Manager , Regulatory Affairs is a working...regulatory strategies to ensure successful review by global regulatory authorities. * Directs submission related activities… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …lieu of your manager , represents RA Ad/Promo and Labeling on RA Project Teams, at cross-functional submission team meetings, and joint labeling meetings with ... campaigns. You may represent RA Ad/Promo and Labeling in Regulatory Project Teams. You may also attend...drug labeling + Experience guiding development and implementation of regulatory submission of promotional materials for prescription… more
- Novo Nordisk (Princeton, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory ...meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders + Write Regulatory documents translating… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - Digital Health Technology** will provide support for… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC is ... Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct… more
- AbbVie (Irvine, CA)
- …Lead (GRL) and project team. Plans and prepares (or oversees) complex regulatory submission documents primarily for US regulatory filings, ensures ... Allergan Aesthetics on LinkedIn. Job Description Description The Sr Manager Regulatory Affairs represents US regulatory...strategies and policies. Duties and Responsibilities: + Represents US Regulatory in project teams. Develops US … more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager ** position is an onsite opportunity ... changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging issues throughout… more
- Pfizer (Kalamazoo, MI)
- …Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication ... will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to… more
- AbbVie (Irvine, CA)
- …Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing ... Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory … more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and ... **Essential Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides...submissions in support of development programs. This includes initial submission of INDs, CTAs, and amendments to Health Authorities… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies for ... CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages. Plans and prepares CMC regulatory packages,… more
- Abbott (St. Paul, MN)
- …for the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Manager ** to join our team in St. Paul, MN. In ... a team of regulatory specialists + Represent Regulatory Affairs on cross functional project teams... agencies. + Interact, answer questions and negotiate with regulatory agencies during the submission review process… more
- Philips (Chicago, IL)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by ... registration submissions for the US, Canada, EU, and support submission preparation for all regulated markets. + Review and...country specific issues or other unique characteristics of the project . + Keep abreast of current regulatory … more