- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs ... Molecules Development, Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in Lexington, MA ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies ... in a scientific discipline with minimum 5+ years of experience in a global CMC regulatory affairs position (with expertise in biologics and deep experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... global amendments + Coordinate and facilitate development of Regulatory CMC strategy with development teams, affiliates...a global matrix team environment, successfully managing CMC Regulatory activities and initiatives + Deep… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...regulatory agencies. + Responds to global regulatory information requests. + Develops strategies for CMC… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Ascendis Pharma (Palo Alto, CA)
- …, Regulatory Affairs will be responsible for supporting and developing global regulatory strategies for the oncology pipeline products encompassing clinical, ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more
- Bristol Myers Squibb (Seattle, WA)
- …applications while upholding regulatory requirements. + Extensive knowledge of applicable global regulatory standards which apply to both ATMPs and sterility ... their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director, Global Sterility Assurance...they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we are** ... a difference with. **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... technical objectives (project and scientific related) with input from manager as needed. + Identify and recommend vendors as...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, … more
- West Pharmaceutical Services (Exton, PA)
- …priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information request responses, change notifications, and ... regulatory planning and support the development of global regulatory strategies, with consideration of latest...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …regulatory affairs + Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology + Has ability to ... playing to win CMC strategies that are in alignment with the Global Project Teams (GPTs) and Therapeutic Area Units (TAUs) strategies/goals/KPIs. + This role… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …modalities. + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC strategies to enable ... If so, be empowered to take charge of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here, everyone matters and you will be a… more
- Takeda Pharmaceuticals (Boston, MA)
- …to simultaneously driving regulatory approval as well as product launch and global patient access + have the ability to partner with all functions to drive, ... directly accountable to the GPL on the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program;… more
- Lilly (Indianapolis, IN)
- …teams towards an established timeline that meets customer requirements and supports CMC and Regulatory timelines + Responsible for Tech Transfer Plans/Reports ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Takeda Pharmaceuticals (Lexington, MA)
- …etc.). + Experience in global product launches and the associated CMC regulatory requirements. + Provide leadership for important deliverables, identifying ... with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs, while serving as an important point of… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC , Graphics, Legal, Quality, Supply ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...our collective progress and impact. **OBJECTIVES/PURPOSE OF JOB** Labeling Manager is responsible for leading labeling artwork projects for… more
- Integra LifeSciences (Plainsboro, NJ)
- …what's possible and making headway to help improve outcomes. This **Senior Manager , Quality Operations** will manage and provide oversight on Quality Compliance for ... ISO 13485, the medical device directive, and the other applicable regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director, … more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA Req #339 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in the oncology ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....and expanding mid-size company in the role of Sr. Manager , Outsourcing and Vendor Management. Your expertise will play… more