- Merck & Co. (Rahway, NJ)
- …to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and obtain shortest ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including hands on related pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience Advanced knowledge ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (North Wales, PA)
- …maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of ... communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …studies, product registrations, and commercial products. An Associate Director, Regulatory Affairs will be a key member of project teams and teams ... responsible for evaluation of product concepts.Essential Functions/ResponsibilitiesDevelop and implement regulatory strategies to facilitate the progress of… more
- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... provide recommendations to Regulatory CMC leadership team as appropriate.Provide regulatory leadership as needed in product in-license/due diligence review, … more
- BioAgilytix (Durham, NC)
- …timelines as well as the preparation of submissions.Essential ResponsibilitiesProvides guidance to product core teams to ensure that all regulatory submissions ... you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and ... implementation of global regulatory labeling strategy for Insmed marketed and to-be-marketed productsResponsibilitiesIn close collaboration with Regulatory … more
- Aequor (TX)
- …NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of ... regulatory support, review and approval of applications with the...for all Notified Body projects. Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... descriptionThis position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device… more
- Tris Pharma (Monmouth Junction, NJ)
- …other strategic initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC, New Products, ... than 150 US and International patents including applications and several brand and generic product approvals in the US and globally. We have an immediate opening in… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... tracking, documenting and processing adverse event reports received for assigned product , including the timely review and distribution to co-marketing partners and… more
- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations,… more
- Aequor (NJ)
- …external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements. Monitoring long-term ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful candidates will be able to ... required Experience Qualifications- 4 or More Years Experience in a corporate, product or internal communications position required- 4 or More Years Experience… more
- Bakerly LLC (Coral Gables, FL)
- …and bakerly 'savoir-faire'. The Position: We are looking for a dynamic and experienced Product Manager in the food industry to join our team. The Product ... role will involve collaborating closely with cross-functional teams to drive product developments and achieve business objectives. Responsibilities of the Marketing … more
- Catalent (Philadelphia, PA)
- …regulatory bodiesAnticipates internal and or external business challenges and/or regulatory Issues; recommends process, product or service ImprovementsPerform ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety, and regulatory compliance. Address recurring ... deviations and health authorities' observations as a priority. CAPA Management: Oversee the timely implementation and effectiveness assessment of corrective and preventive actions identified during investigations. Ensure prevention of recurrence and… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, ... centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be… more
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