/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide

Assist in the preparation of external reports, ESG disclosures, and surveys such as CDP, EcoVadis, S&P Global and others. Assist in the collection, analysis and management of data for ESG reporting frameworks and support work processes, policies, etc. Collaborate with various teams to address customer inquiries and requests related to ESG topics. Proactively identify oppo

. Work Schedule and Additional Information Full time employment, 37.5 hour work week Work hours are 8 30 AM to 5 00 PM, Monday to Friday, with 60 minute lunch. May change based on operational needs. The Department of Human Services provides excellent benefits, contractual pay increases, paid holidays and leave entitlements, opportunity for advancement and shift selection

The Policy Advisor is a key member of the policy team, reporting directly to the Policy Director. This role involves providing strategic advice, conducting in depth policy analysis, and assisting in the development and implementation of policies, initiatives, and strategic priorities for Montgomery County. The Policy Advisor plays a critical role in supporting decision ma

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

The Pennsylvania Director of State Affairs serves as the principal staff for state government affairs and chief lobbyist in Pennsylvania, representing the Alzheimer's Association before Pennsylvania's legislature, governor, relevant state agencies, community stakeholders and coalitions, and on statewide task forces and work groups. This position is responsible for impleme

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

As a combined organization, and is undertaking what is perhaps the central challenge of our times to help drive the transition to net zero carbon economies while ensuring that no working families, businesses, or local communities are left behind. To do that, we are the utility industry's top provider of turn key energy efficiency and grid optimization programs and product

FuturePlan is the nation's largest third party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds high touch personalized service from local TPAs backed by the strength and security of a large national firm, Ascensus. Our roots go back decades, with nearly 30 outstanding legacy firms now joined t

Develop and administer trade compliance training to functional teams to enhance competencies in operational business scenarios. Collaborate with legal, finance, tax, and other functions as needed to make relevant trade compliance determinations. Develop, maintain, and communicate standards to operational teams via master data or other databases to facilitate business flow

Parexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe. In this role you will provide leadership in all regulatory an

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the client solutions compliance team and will play an integral part of supporting client facing activities for the public markets business. At Macquarie, we are working to create lasting value for our communities, our clients

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the Core Compliance team and will play an integral part of driving governance and implementing compliance frameworks. At Macquarie, we are working to create lasting value for our communities, our clients and our people. We ar

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i