RANGAM CONSULTANTS

About RANGAM CONSULTANTS

This is an onsite role This is a long term project HM top 3 Flexibility with hours Steady work history Regulatory experienceImportant Update from the manager BS degree with 4 years pharmaceutical or industry related experience Regulatory publication exp will also help Looking for regulatory Project management experience Candidate would be working on regulatroy submission Looking for regulatory affairs experience PMP and RAC certificates a plus Working on IND CTA and all amendment’s Familiar with regulations and global exp to work with global market Should be available to take evening 8PM to 9 Pm calls (they can take calls from home) IND and CTA submissionDescription: Trial Master verification process Worldwide Marketing Authorization report support Writing documents to be included in submissions (e.g., SPL) Managing SharePoint sites to ensure update to date, organized, accurate and accessible information Assisting with submission documents such as financial disclosure, user fees, and Notes to reviewers Coordinating and providing input to responses to Competent Authorities or PRAC and/or CHMP safety questions, ad-hoc safety-related labeling changes, and significant safety events Supporting annual and safety reporting (e.g., DSUR, PSUR, BLA, NDA, PMR, PADER, IND, ODD) which may include working with cross-functional groups to obtain required information to complete activities, editing, review, and approval of summaries, and completing submission of the completed reports. This position interacts with multiple individuals involved in global regulatory strategic activities. The position, under supervision of the manager, supports the Global Regulatory Leads (GRL) and US/Canada Leads in completing various reporting activities to regulatory agencies worldwide. Under the direction of the GRL and/or US/Canada lead, activities include Editing, review, and approval of summaries for annual reports and PA Conducting surveys to countries which may include assessing global regulatory requirements for whether a change requires reporting, the type of reporting, or the reporting requirements for significant safety events * Requesting HAQIT (internal database) entry of Regulatory Response Questions Maintaining the Closed Loop trackers for follow up activities Drafting, approving, and signing (on behalf of area lead): cover letters, 356h forms, 2252 forms Entering documents into Client Connect (e.g., submissions, correspondence, resolving correspondence questions, closing out records) Advisory Committee planning support, including vendor interaction, consultant management and invoice approval, meeting coordination Time-permitting, assisting department with competitive intelligence tasks, including reviewing and presenting competitor labels and submission strategiesMust have the following: Needs to be able to organize and prioritize tasks and work independent of manager. Be able to think of new and better ways to accomplish tasks. Work with all team members to accomplish tasks and be able to clearly communicate with the team to get clarity when needed. Needs to do writing for routine submissions. Review submissions with a critical eye for typos, grammatical errors, pages out of order, etc. A basic understanding of scientific disciplines required. Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired. Good computer skills required.Education Requirement: Science (biology, chemistry etc.) degree required; health degree (e.g., nursing or other health related discipline) preferred. Job Type: Contract Salary: $50.00 to $55.00 /hour Experience: Regulatory Submissions: 4 years (Preferred) IND and CTA submission: 4 years (Preferred) regulatory Project management: 4 years (Preferred) Regulatory Affairs: 4 years (Preferred) Education: Bachelor's (Preferred) Location: North Chicago, IL (Preferred) Contract Renewal: Possible

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Company Info

Legal Form: Inc

Company Type: Private

Company Size: 501 - 1000

Revenue: 25 - 100 million (USD)

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