Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter

Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

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

State and Local Government Account Executive MA, RI, VT, NH, ME Job Locations US NC Cary HQ | US MA Requisition ID 20060332 Category Sales/Pre Sales Visa Sponsorship No Travel Requirements 50% Location Strong preference for New England or North Carolina based candidate. Nice to meet you! We're the leader in analytics. Through our software and services, we inspire customer

OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu

The Contracts Associate will handle Subsidiary Rights licensing agreements for the various publishers in the Macmillan Trade group of publishers, including Celadon Books, Farrar, Straus & Giroux, Picador, Flatiron Books, Henry Holt & Co., Metropolitan Books, St. Martin's Publishing Group, Tor, and the Macmillan Children's Publishing Group. The Associate will be responsibl

MLTC Dir of Contracts/Compliance Job Locations US NY Bronx ID 2024 4997 Category Regulatory Compliance Position Type Regular Full Time Overview RiverSpring Health Plans serves over 16,000 frail individuals and help them live in their homes and independently for as long as possible. Join our compassionate and dedicated team and make a difference in the lives of our members

The Interoperability Regulations and Standards, Director will work with key external stakeholders to summarize lab related industry standards and regulations and translate any business impact to internal stakeholders. When impactful, this role will be responsible to coordinate internal stakeholders to further assess any impact and help establish solutions. The role will c

The Manager, Regulatory Affairs Operations is responsible for supporting the development of documents created for, and as a result of, worldwide regulatory submissions. The incumbent utilizes and supports systems and processes by which regulatory documentation (internally generated or received) is created, approved, submitted, and maintained for use and made readily searc

The Associate Director, Regulatory Affairs CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements. This position works cross functionally with Regulatory Af

Drafting and editing Citi's responses to the Regulatory Consent Orders and related transformation efforts across businesses, functions, and regions, as needed, acting in close collaboration with the Transformation Office, the Transformation Central Legal Team and the CAO Office, among others Strategic thought leadership around effective representations of Citi's work to i

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus

Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus