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This position will assist with the preparation and submission of ANDAs, Amendments, Supplements and Annual Reports to appropriate regulatory agencies. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Works with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups, Information Technology, and other departments as needed. May submit submissions for changes to labeling, QC, manufacturing, or distribution practices. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Department procedures, as needed. Responsibilities Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guidelines. Prepare paper based and electronic submissions, including both eCTD and non-eCTD formats, for multiple project to regulatory agencies, and ensure the timely delivery of quality submissions. Critically review submission documentation and provide input to respective departments for necessary revisions. Coordinate and prepare responses to FDA Deficiency Letters and other agency requests. Using eCTDXpress complete submission publishing for submission through ESG.
Paid or Unpaid: Paid

 
AG technologies is an IT Software Services Company located in Chesterfield, MO, and armed with a strong team of software professionals, we use a low risk global delivery model. AG technologies combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work.
Paid or Unpaid: Paid

 

Greetings

I wanted to reach you today regarding many outstanding opportunities across a range of projects and skill requirements throughout the US.  We do H1B Transfers and Green Card Processing. 

Experienced consultants with L2 Visas OR looking for E3, who can start working on projects are welcomed too.

We are in the process of hiring candidates on a fulltime basis for SUBU  and looking for Developers / Engineers / Professionals who can transfer their H1s or who needs GC sponsorship.

Paid or Unpaid: Unpaid

 
Hiring E3/L2 EAD & H1b transfers @ attractive package or % basis at vidya@subullc.com/609-945-1651

We are in the process of hiring candidates on a full-time basis for SUBU  and looking for Developers / Engineers / Professionals who are on OPT or who can transfer their H1s or need GC sponsorship. best compensation like 80/20 model or even attractive for senior profiles
Paid or Unpaid: Unpaid

 
This is Vidya Sagar from SUBU LLC I wanted to reach you today regarding many outstanding opportunities across a range of projects and skill requirements throughout the US. We do New H1B Sponsorship / Transfers and Green Card Processing. SUBU LLC is a new generation company delivering IT consulting, enterprise-wide software solutions and IT support services by leveraging industry experience and technology innovation. We provide a broad spectrum of business and technology services to our clients worldwide. Our core portfolio of services include Advisory Services, application development, project or strategic staffing solutions, and business process outsourcing for our customers in financial services, telecommunications, healthcare, pharmaceutical, retail industry and government. We are looking for talented professionals to join our Consulting team. We offer our consultants excellent benefits and our financial relationship with our consultants are based on building a trusting long-term relationship that benefits all. If necessary, we will match the candidate’s areas of interests to our training capabilities, provide training and prepare them for jobs in emerging areas of technology. We are in the process of hiring candidates on a fulltime basis for SUBU and looking for Developers / Engineers / Professionals who are on OPT or who can transfer their H1s or who needs new H1 or need GC sponsorship.
Paid or Unpaid: Unpaid

 
Technodrive Business Solutions Inc is one of the fastest growing and exciting technology companies. Technodrive Business Solutions Inc provides cutting edge solutions development based on the latest advances in open software design and integration. The company is best known for not only understanding our customers needs implicitly, but also consistently exceeding their expectations in our efforts. Technodrive Business Solutions Inc is supported by a strong and dedicated team of technology professionals with extensive domain knowledge in many verticals.
Paid or Unpaid: Unpaid

 
SAP Training in FICO, Basis, ABAP, SD, MM, WM, PP, GTS, Testing Sage Group Consulting is a premier SAP Solutions and Delivery company focused in new dimension products and emerging technology solutions. Primary focus is my SAP ERP, Business Intelligence, Human Resources, CRM and application integration solutions. Sage Group provides Information Technology services to Fortune 500 customers by applying proven business and technology solutions. Internship Program: We have online and onsite both kind of training's. We are charging $1000 (Individual case depended) for the 56 Hours training. After completion of your training, we will provide you some real time projects for your practice. You have to work on that minimum 1 week. Your 24/7 system access: The request for your system access will be put after your first class and you should receive your system access and connection details by end of next day. Class Agenda: Your trainer will go thru the slides, demonstrate in SAP, help you to practice in the class, will give you an assignment to work on and go over the assignment key in detail once the assignment is done. After class support: In case if you have any questions on the class and if you would like have some help, please email sales2@sageci.com. Next step: Email back if you are interested and we will initiate the training program on registration process. Within 3 days we will assign you a batch after getting your training registration fee and form. Very small Class size For more information, please feel free to call on 610-621-2135 (Nikhil) or Email: sales2@sageci.com Highlights: SAP System Access Class Assignments Class Practice sessions Live & Interactive Training with Project leads Interview Prep Sessions Small class size & personalized attention (Max -5 trainees in a class) Option to Upgrade to Our Real time Live Project to Implementation Program
Paid or Unpaid: Paid

 
We offer training / job placement service for the following technologies:  Hadoop • Tableau ,Software Configuration Management ,Ruby on Rails
Paid or Unpaid: Paid

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