The Associate, Regulatory Affairs will work with Regulatory Counsel in regulator and entity relationships, cover important legislative and regulatory hearings and meetings as assigned, and supports the Regulatory Affairs function by serving as an enterprise wide resource on public policy and IDR tre...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Support CMC development activities from a regulatory standpoint du...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. As a Facilities Compliance Specialist, a typical day might include the following:. Managing and part...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. In this fast-paced environment with a strong pipeline, our Associate Compliance Specialists have an opportunity to work on countless aspects of the process and business. As s Compliance Specialist- ...
Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, EMA and other regulatory authorities. This role includes overseeing regulatory affairs staff, various outside contractors, supporting pr...
A typical day might include the following:Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supplyCollaborates cross-functionally to support the submission strategies and impacts on supply and regul...
Senior Environmental Regulatory Specialist. Senior Environmental Regulatory Specialist - Energy | Vermont or Albany, New York office preferred. VHB is seeking a Senior Environmental Regulatory Specialist to join our Vermont/upstate New York operation's Energy Services practice. It will primarily inv...
Within our Regulatory Affairs and Compliance team, the Senior Regulatory Affairs & Compliance Strategist is responsible for the oversight of the Healthcare compliance reviews for the release of Oracle Health products. We are leading the industry in using big data intelligence to enable the shift fro...
Duties include, but are not limited to: scope development, justifications and estimates for capital, alteration and rehabilitation projects, preparation and review of Requests for Qualifications (RFQs) for professional design consultant services, consultant selection and procurement, assistance to t...
In this role, you will work side by side with the project manager to coordinate and accomplish the necessary project tasks and requirements. Assist the project manager in the execution of the management plan for assigned projects. Track and directly report project status updates to project manager. ...
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolutio...
Business Analyst, Compliance Technology- IT. Business analysts may be assigned by project, line of business or technology platform and are expected to participate in every stage of the development lifecycle, from analysis and design through testing, release and maintenance while adhering to current ...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
Bachelor’s degree in a related field .Related work or internship experience preferred!.Strong Excel experience needed!.Requesting documents, facilitating workflow updates, a variety of administrative tasks, a variety of tracker maintenance and updates.Ensuring Corrective & Preventative Actions are a...
The salary range for this position is noted within this job posting.Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and...
With 20+ years of uninterrupted growth, we are seeking a HR Benefits Administrator and Compliance Specialist to support our growing Americas region. As HR Benefits Administrator and Compliance Specialist, you’ll play a pivotal role in shaping the Access employee experience. Bring your experien...
Issuing non-compliance notices when vendors and/or funding recipients are not in compliance. Minimum 3-4 years of experience in the review, investigation, and/or evaluation of compliance with EEO laws, rules, and regulations or the planning, development, implementation, and review of programs r...
Cockroach Labs is hiring a Compliance & Risk Analyst to support our Compliance Manager. Collaborate with internal teams to address pre-sales security & compliance questionnaires & attract customers by upholding modern compliance programs. In your second month, you will become an integrated member of...
Description & Requirements The Compliance Management Analyst will support OS in various aspects, including, but not limited to, OS Security Compliance, collaboration with OS Staff Divisions (StaffDiv), coalition building, and awareness programs that promote all OS Cybersecurity initiatives. Thi...
Fortress Investment Group seeks an entry level Compliance Analyst to join the Fortress Compliance Department. The successful candidate will work with members of the Legal and Compliance Department and other departments and businesses around the firm on, among other things, the following major items:...
Capital is looking to hire a Tax Compliance Analyst to join the Fund Finance Central Services team. Coordinate closely with Fund Finance teams to streamline the payment process, ensuring efficiency & compliance with financial regulations, & responsible for timely & accurate submission of tax payment...