- 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
- Corteva Agriscience (Johnston, IA)
- …of humankind. Corteva Agriscience has an exciting and challenging opportunity for a Global Regulatory Project Manager (GRPM) in the Global Registration Team ... within Global Regulatory Affairs. The global project ...plans as needed throughout the year. + Actively manages regulatory program implementation, including study timelines, submission … 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
- J&J Family of Companies (Cambridge, MA)
- Manager , Regulatory Program Manager (RPM)...team efforts. The RPM will serve as the primary project management point of contact to ensure Regulatory ... 2406191837W **Description** Johnson and Johnson is recruiting for a Regulatory Program Manager , Oncology. This position can... Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management,… 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
- Medtronic (Boulder, CO)
- …in a more connected, compassionate world. **A Day in the Life** As the Regulatory Affairs Manager , you will be responsible for establishing strategy for ... submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The... compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish… 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
- ThermoFisher Scientific (Fremont, CA)
- …for worldwide product approval submission activities, directly responsible for submission activities and for ensuring regulatory compliance. * Implement ... CAPA, HHE, issue assessments). * Facilitate and prepare US regulatory Pre Submission documents and pre ...technical documents; * Acting as the RA representative on project core teams providing active and successful regulatory… 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
- 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
- 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
- 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
- BeiGene (San Mateo, CA)
- …of Regulatory end-to-end process from document authoring and management, submission publishing and validation, to regulatory information management and ... RIM function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA,… more