QC Lab Operations Specialists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Perform duties to accord w/ company policies + procedures, SOPs, + state, federal + local laws. Test raw materials, In process, extended release Intermediates, Finished Product + Stability samples, incl dissolution, assay, preservatives, Related Compounds analysis, content/blend

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. You will lead a global team of regulatory professionals to establish business strategie

/JOB PURPOSE Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company wide initiatives around end to end labeling and provides dedicated support on Regulatory related activities and deliverables. This role requires an e

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 30 2024 Are you looking for a highly visible role where you can ensure the development and execution of appropriate strategies across all stages of the product life cycle consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP)? If so, this role could be an exciting op

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

Site Name UK Hertfordshire Ware RD, Durham Blackwell Street, GSK House, USA Pennsylvania Upper Providence Posted Date May 2 2024 As Regulatory Manager for devices, you will manage the overall global regulatory and advocacy strategy for GSK's portfolio of combination product devices (injectable and inhalation) across modalities and lifecycle We create a place where people

Provide quotes and develop agreements for Government Accounts based on direction provided by the US Sales Organization, revising as needed throughout the negotiation process. Amend and restructure existing group customer agreements when required. Track the status of new offers to measure win rates and cycle times. Cultivate a strategic partnership with the Sales Organizat

The Corporate Product Safety and Regulatory Affairs team has an opening for a PS&RA Manager, responsible to support the High Performance Polymers (HPP) business unit. In conjunction with the HPP business for which this position is responsible, the PS&RA Manager manage activities to assure compliance with legal and corporate product safety and regulatory affairs requiremen

Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation inspiring complex change, enabling organizations to grow, building competitive advantage,

Site Name UK London Brentford, Belgium Wavre, USA Pennsylvania Upper Providence Posted Date May 10 2024 We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be o

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

Core member Nourish Ingredients Ops team to Understand business partner needs and advise on strategic opportunities. Create, evaluate, and qualify pipeline of opportunities to generate value to the business. Strategy Coordinate the development of the site Ops Goal Alignment document (former A3), which includes the key areas to focus for the site and the operations KPIs an

Collaborates in the development of communications strategies tailored for target audiences over multi channel platforms, and leads the execution of those efforts to inform, educate, and influence both internal and external audiences. Develops integrated communications strategies to reach key audiences, oversee implementation, and measure results. Develops message framewor

The FDA Center for Tobacco Products requires the assistance of minors ages 16 17 and those under age 18 20 to attempt the purchase of tobacco products from local tobacco retailers. The goal of the program is to ensure tobacco retailers are complying with Federal laws and regulations that prevent them from selling tobacco products to minors. This will be a part time, posit

What We'll Bring At TransUnion, we strive to build an environment where our associates are in the driver's seat of their professional development, while having access to help along the way. We encourage everyone to pursue passions and take ownership of their careers. With the support of colleagues and mentors, our associates are given the tools needed to get where they wa