1 to 12 of 12
Sort by: Date | Relevance
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
Posted Today
Vanasse Hangen Brustlin Inc.
- New York, NY / Hauppauge, NY / Newark, NJ
Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel
Posted 14 days ago
IPG Health
- Parsippany-Troy Hills, NJ
The Regulatory Operations Specialist's main responsibility is to manage regulatory submissions and associated tasksfor 1 3 client brands while following industry standards, as well as agency and client established processes. The Specialist will partner with agency brand teams to help prepare and upload submission materials into client submission portals. This role require
Posted 8 days ago
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
Posted 23 days ago
OF POSITION Independently authors, compiles, reviews, schedules, and submits high quality regulatory submissions in adherence with technical document 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 submiss
Posted 21 days ago
Internal Revenue Service
- Anchorage, AK / Fairbanks, AK / Birmingham, AL / 425 more...
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
Posted 1 day ago
CMC Regulatory Strategy Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC projects. Develop solutions to regulatory or business problems where no clear precedence exists. Submissions for Development and Commercial Products Lead activities, including planning and reviewing US CMC sections of all regulatory submissions (i.e.
Posted 14 days ago
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
Posted 27 days ago
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
Posted 27 days ago
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
Posted 28 days ago
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
Posted 28 days ago
The Director, Interoperability Regulatory Lead will work with external and internal stakeholders to identify and summarize lab related industry standards and regulatory requirements relevant to Quest Diagnostics, highlight business and digital solution implications, and facilitate solution design with internal stakeholders. The Director will also serve as a Quest represen
Posted 1 month ago
Email this Job to Yourself or a Friend
Indicates required fields