This position will provide Regulatory Affairs oversight to Laerdal to assure FDA and Health Canada medical device and establishment requirements are met and both Laerdal Medical Corporation (LMC) and Laerdal Medical Canada (LMCA) remain compliant to medical device regulations. This position will provide Quality Assurance oversight to both the Laerdal Medical Canada (LMCA)

We are searching for a candidate to provide North America (including US and Canada) regulatory support for IFF Health and Biosciences business unit with focus on dietary supplement ingredients. The successful candidate will work as part of a global regulatory team within IFF Health and collaborate with internal business partners including R&D, Quality, Commercial and Mark

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

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

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

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

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 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

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

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

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