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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 1 day ago
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
Posted 11 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 9 days ago
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
Posted 3 days ago
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 15 days ago
What success looks like in this role In this role you will Assist and handle public inquiries on civil registry documents such as birth certificates, marriage contracts and other important documents. Performs administrative tasks for frontline or backend operations which may include responding to customer inquiries and data encoding Operate a data entry terminal or comput
Posted 23 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 24 days ago
Lead Chatham's US Regulatory and Documentation practice, a unified team supporting all of our client sectors in navigating applicable regulations Collaborate with the International Regulatory and Documentation practice lead to ensure an appropriate degree of alignment in processes, priorities, and talent development Partner effectively with stakeholders outside of direct
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 2 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 22 days ago
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
Posted 8 days ago
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
Posted 17 days ago
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
Posted 8 days 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 15 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 28 days ago
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