Active Haleon Representative on Industry association, CHPA, and relevant Wellness associations in region and globally as appropriate Lead Wellness regulatory intelligence evaluation and communication process to guide strategic portfolio choices. Regulatory lead on governance and management of current/emerging wellness ingredient issues and risk management. Set Wellness Re

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

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

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

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

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

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

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

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

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

Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks. Collaborates with local site teams (e.g., IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and aud

US Regulatory TA Strategy Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory expertise and

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

The Government Relations Associate serves as a member of the Museum's government and corporate relations team and is responsible for helping administer all facets of the government relations program at AMNH . This position will support the Vice President and Director of Government Relations. Responsibilities include, but are not limited to Administrative duties including