- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing ... following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions, including… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global ... Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... other strategic initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC, New Products,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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… more
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …various product teams and global manufacturing sitesProvide updates to Senior Management on site validation status activitiesProvide validation training to staff ... in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the… more
- Eisai, Inc (Nutley, NJ)
- …Responsibilities Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in sales, ... organization by enhancing the capabilities of the Sales Team through initial product training, advanced product training, improved selling skills, disease state… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... is the GPT Leader, directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …discussions.Support the Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance ... at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety, and regulatory compliance. Address recurring… more
- STERIS (Alpharetta, GA)
- Senior Manager , Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At STERIS, we ... required documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have… more
- TD Bank (New York, NY)
- …Business:** Compliance **Job Description:** **Department Overview** The Senior Compliance Manager - Credit Card Regulatory Oversight will be largely focused ... support for external regulatory exams or internal audits + Conducting regulatory research + Communicating with external examiners, senior management and… more
- AbbVie (Lake Bluff, IL)
- …presented for registration worldwide. The individual represents the organization at Senior level meetings regarding combination product and device labeling, ... combination product and device submissions and seek clarification on regulatory requirements; provide regulatory guidance and support to internal… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve ... regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure ...promotional and disease state materials. * May present to senior management, and present regulatory topics to… more
- dsm-firmenich (Princeton, NJ)
- Senior Regulatory Affairs Manager ,...for product approval in collaboration with R&D, product and project management, and regional regulatory ... Pharma North America Location: Plainsboro, NJ Hybrid As Senior Regulatory Affairs Manager , Pharma...to date. Manage FDA API import reporting. + Develop regulatory assessments for product portfolio specifically for… more
