Regulatory Affairs Associate Jobs
Our client is currently seeking a International Regulatory Affairs Associate. International Regulatory Affairs Associate I is a position in the Regulatory Affairs department for individuals with direct pharmaceutical experience and a BS in a scientific discipline. • Assist in providing a wide variety of documentation related to a broad product line for submission to various worldwide health agen...
Job Summary The Regulatory Affairs Associate II is responsible for monitoring regulatory activities in assigned markets and for ensuring that all domestic and international regulations and guidelines are met. Help maintain established procedures and processes to assure regulatory compliance, and provide support to product development, quality assurance, marketing and other departments. Essential...
Job Responsibilities - Define global CMC regulatory strategy for ANDA filing of injectable products and manage the preparation, assembly and review of the quality (CMC) sections of regulatory submissions. - Liase with FDA in written communications - Coordinate responses to global regulatory agencies dealing with quality sections of global regulatory submissions Qualifications - At least bache...
JOB SUMMARY: Compile, review and transmit eCTD submissions to FDA. Maintain indices, records and processes for all regulatory applications. Maintain GDUFA Self-Identification processes. Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality eCTD submission information to support company goals and objectives. ESSENT...
We are always hiring, because Vascular Solutions is always growing. Successful both clinically and financially, we provide meaningful work, financial rewards and rapid growth opportunities for employees who want a chance to achieve based on their own merits. Please review the responsibilities and requirements of the position below. If you would like to join the nation’s fastest growing medical de...
Overview Do YOU have great ideas? Want to work in an environment that will nurture your professional development? Come and join Teva on its journey of growth. Teva has been cultivating excellence for over a century, and is, today, a worldwide leading generic pharmaceutical company and one of the top 10 pharmaceutical companies in the world. As a forward-looking global pharmaceutical company, Teva...
Our client is currently seeking a REGULATORY AFFAIRS ASSOCIATE - Contract position BA/BS in Scientific discipline required. Engineering strongly preferred RAC certification desired Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Participate in cross functional team activities from initial stages to securing goven...
Regulatory Affairs Associate (Spring Valley, NY) " Resrch & file ANDA submissns, supplement submissns, annual reports, & Adverse Event Reportg. Req MS in Chem or Pharmceutcl Chem + 2 yrs exp in job offrd. Req skills & knowldg of ANDA/NDA, Analytical method developmt & validatn, USP/NF, 21 CFRs FDA guidelines, CTD/eCTD, solid orals/injectables & opthalmics. Send res w/code REC001 to HR, Par Pharmac...
Job Title: Regulatory Affairs Associate III Position Description Provides regulatory affairs support and expertise by preparing drug and device registration packages for FDA product listings and documentation to facilitate the importation of product into the US. Serves as a lead regulatory representative for assigned project teams. Supports US drug shortage management. Support global device r...
BRECKENRIDGE PHARMACEUTICAL, INC. REGULATORY AFFAIRS ASSOCIATE This position supports the Regulatory Affairs Manager in day to day activities to ensure the timely compilation and submission of ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA. Location: CT Job Responsibilities Include: Review technical/regulatory/clinical documentation...
Requirements: Minimum of a BS with 1-3 years’ experience in Medical Device industry Recent Experience with complaint investigation and MDR/Vigilance reporting preferred Excellent working knowledge of US (QSR) and OUS Quality Systems (ISO 13485) Responsibilities: Receive, document, and respond to product complaints according to global regulatory requirements, and SOPs Process product complain...
Company: Yoh Regulatory Associate needed for a contract opportunity with Yoh's client located in Research Triangle Park, NC area. What You'll Be Doing: - Maintenance of high quality, detailed data using varied information sources required to generate notifications to support global regulated processes. - Liasing closely with other personnel to ensure the quality and accuracy of generated notif...
System one has engaged with a top client in seeking a Senior Regulatory Affairs Associate in Miami, FL. The duties of the incumbent will be review and ensure proper documentation for all regulatory functions within a specific division. Acting a liaison in meetings to ensure compliance in various matters is happening will be required also. The Senior Regulatory Affairs Associate will be required t...
Essential Duties and Responsibilities: • Convert MS Word documents in a legacy format to ISIWriter using a custom conversion tool, ensuring that the correct styles and formatting are applied to the document • Additional cleanup when legacy documents are not in the correct format, either pre- or post-conversion • Verify document granularity is correct (e.g., headers, and first heading) and fix if...
Quintiles Overland Park, KS
Description This role is office based in our Overland Park, KS office RESPONSIBILITIES • Creates an inventory of appropriate regulatory documents based on checklists prepared by Regulatory personnel. • Identifies project needs, tracks project timelines and implements client requests, with senior review. • Reviews documents for regulatory completeness, consistency and accuracy, interacts with ...
3M Company London, MN
Job ID:62905 3M is seeking a Product Regulatory Affairs Associate for the Corporate Regulatory Affairs team located in London, Ontario. Ready to be part of what's next? The successful candidate will focus on: - Providing key guidance and assessments to 3M Canada businesses in the area of product chemical regulatory compliance development and maintenance of product regulatory compliance programs...
AstraZeneca Gaithersburg, MD, 20877
Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland . MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription me...
Description Compile and submit, in a timely manner, regulatory documents according to regulatory requirements Support: 510(k)s 510(k) pre-Submission meetings PMAs IDEs Pre-IDE meetings Technical Files Design Dossiers Global Product Registrations Product Licenses Support the Quality Management System Support Regulatory Submission Plans Support Regulatory Leads on Product Development C...
Description Participate on Global Regulatory Teams Participate/Lead CMC Focused Sub-Teams Owns CTD Module 3 and DMFs for assigned files Primary Contact with R&D Technical Staff (CMC areas) Defines Global CMC Strategies Post Approval Changes (change control) Annual Reports (CMC section) Facilitate/Contribute to Baxter’s Policy and Positions on CMC Standards Regulatory liaison with manufact...
Sanofi-Aventis Allston, MA
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to...
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Regulatory Affairs Associate
$38,760.00 - $94,500.00
Typical Salary for Regulatory Affairs Associate
Source: Monster.com Careerbenchmarking Tool
Education / Training
Some College Coursework Completed
Source: Monster.com Careerbenchmarking Tool
Regulatory Affairs Associate
Ensures regulatory compliance by determining submissions requirements; assembling and preparing submissions; collecting and providing information.
Rate of Growth
Size of Industry in 2006:
Source: Bureau of Labor Statistics, May 2006
Protects organization's competitiveness by keeping information confidential.
Determines submission requirements by reviewing requirements involving the Food and Drug Administration (FDA); Center for Biologic Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), drug master files (DMFs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), pre-market approvals (PMAs), investigation new drug (IND) applications, and chemistry manufacturing and controls (CMC).
Popular Regulatory Affairs Associate Articles
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