- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Avidity Biosciences (San Diego, CA)
- Job Title: Associate Director - Regulatory AffairsLocation: San Diego, CA / Hybrid / RemotePosition type: Full timeFLSA: ExemptDepartment: Regulatory ... www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.The OpportunityThe Associate Director, Regulatory Affairs is responsible for establishing … more
- LSI Solutions (Victor, NY)
- …I, II, III, and Senior : Base Level from the prerequisite role ( Regulatory Associate ) Essential Functions: + Understand and maintain LSI file structures and ... Labeling Area: Base Level from the prerequisite role ( Regulatory Associate ) Essential Functions: + Accurately complete...Area: + Independently review Instructions for Use. Additionally, All Senior Regulatory Specialists - Labeling … more
- Takeda Pharmaceuticals (Columbus, OH)
- …In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global ... bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you...and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory Affairs, ... <10% **Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is...products. + Have responsibility for review and approval of labeling and promotional material and associated product claims. +… more
- Stryker (Redmond, WA)
- …More information is available at www.stryker.com . We are currently seeking an ** Senior ** ** Regulatory Affairs Associate ** to join our **Medical Division** ... registrations and assist to process registration changes when required. + Provide regulatory information and guidance for proposed product claims/ labeling +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexington, ... and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Astellas Pharma (Northbrook, IL)
- …activities. The individual will have interactions inside and outside of the Regulatory Affairs department, including with members of senior management, on ... will report to the Senior Director responsible for promotion review within US Regulatory Affairs and manage one or more direct reports at the associate … more
- System One (Florham Park, NJ)
- …specific regions, and provide insights to the Senior Director and Associate Director. + Contribute to managing regulatory risks and opportunities related ... Senior Manager, Regulatory Affairs Strategy -...post-marketing activities related to QOL initiatives, including variations, renewals, labeling updates, and compliance initiatives. + Collaborate with the… more
- Pfizer (Bothell, WA)
- …biochemistry, understanding of immunological functions and systems. + Experience with labeling proteins with a small molecule like biotin. Additional Information: + ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Catalent Pharma Solutions (Philadelphia, PA)
- ** Senior Engineer, Quality Operations** **Position Summary:** Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical ... for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to… more
- Amgen (New Albany, OH)
- …10 million patients worldwide. It's time for a career you can be proud of. Senior Manager of Engineering - Process Equipment Lead **Live** **What you will do** Let's ... the engineering design development activities for pharmaceutical combination product assembly, labeling , and final packaging equipment. In this role you will work… more
- Billings Clinic (Billings, MT)
- …Click here (https://billingsclinic.csod.com/ats/careersite/search.aspx?site=15&c=billingsclinic) to learn more! Senior Mohs Technician DERMATOLOGY (BILLINGS CLINIC ... $21.70 - $27.12 Under the clinical supervision of the Mohs Surgeon, the Senior MOHS Technician leads the team in the delivery of patient care/treatment, performing… more
- Banner Health (Phoenix, AZ)
- …are looking to leverage your abilities - apply today. As an Oncology Senior Acute Pharmacy Technician, you will be responsible for cleanroom procedures, IV ... lives better as we aim to prevent and cure cancer. As an **Oncology Senior Acute Pharmacy Technician** , you will be supported by chemotherapy trained Pharmacy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director Neurodegenerative Disorders in our Neuroscience Therapeutic Area Unit in our ... vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for clinical studies focused… more
- Amgen (New Albany, OH)
- …**Live** **What you will do** Let's do this. Let's change the world. In this role as Senior Associate Plant QA, you will be working in a shift system; you will ... production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. ** Senior Associate Plant QA - Night Shift** The Sr. … more
- Lilly (Indianapolis, IN)
- …that clinical data generated for regulatory purposes meets all necessary regulatory standards. *Provide support for global registrations, labeling and label ... to support communities through philanthropy and volunteerism. **Purpose:** The Associate Vice President (AVP) - Cardiometabolic Health Global Medical Affairs… more
- Edwards Lifesciences (Irvine, CA)
- Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed. **How ... * Controlling inventory to ensure appropriate storage conditions, movement and correct labeling of product status * Providing coaching and training to lower level… more
- Abbott (Alameda, CA)
- …way patients and professionals measure, track and analyze glucose levels. As an Associate Director, project leadership, you will be responsible for Managing one or ... budget and on strategy. These activities include coordination of artwork and labeling , in-house and third-party manufacturing, inventory phase in and phase out,… more
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