Browse popular job categories below or search all jobs above, This website uses cookies. The Regulatory Affairs Specialist will be responsible for providing regulatory support to ongoing clinical research trials. You are now subscribed to our push notifications. We will notify you about relevant positions, and keep you in mind when we have interesting opportunities. regulatory affairs jobs Sort by: relevance - date 335 jobs Regulatory affairs specialist new Statistical Pharma Remote in Pune, Clinical Research Associate - Onc - Toronto. WebSearch, find and apply to job opportunities at Stryker, one of the worlds leading medical technology companies. HHS Recruitment Information Webinar Part 2: Get to Know Us Part 2 Join Americas Premier Healthcare Agency. WebOur business encompasses many different functions and capabilities, which allows you to explore careers in various fields. We also use third-party cookies that help us analyze and understand how you use this website. Full Time position. Get notified about new Regulatory Affairs Specialist jobs in United States. These cookies do not store any personal information. A role as a Clinical Research Associate can be fast-paced, challenging and incredibly rewarding. You Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. As a (job title) you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence. ICON is committed to recruiting top talent while also fostering a culture of learning and development within the organization. This post provides complete information on the job description of a regulatory affairs specialist, to help increase your knowledge of what they do. WebThe major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below: Explaining regulations, policies, or procedures. Piper Companies is an elite staffing and human capital solutions firm specializing in information technology, life sciences, and clinical solutions. WebFull-Time Regulatory Affairs Team in the United States or Europe who will provide regulatory support to post-market functional teams and other stakeholders. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. Our rigorous customer engagement process assures results in addressing a variety of people-centered challenges, whether it is helping teams reach maximum performance through comprehensive managed services, directly recruiting permanent employees, or staffing projects on a contract or contract-to-hire basis. Participate in system testing for upgrades by executing scripts and being involved in validation. Experience with regulatory submissions in clinical research (ANVISA. 1985 - 2022 BioSpace.com. They are often responsible for executing several important duties as a result of continuous and constantly evolving regulations worldwide. This website uses cookies to improve your experience while you navigate through the website. You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. Public Affairs Council (Enter less keywords for more results. WebJOB DESCRIPTION Regulatory Affairs Specialist 11. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. The sample job description provided above can help you to effectively describe your regulatory affairs specialist role in the professional or work experience section of your resume. Web646 Regulatory Affairs Specialist jobs available on Indeed.com. Knowledge of Veeva RIM & Vault systems a plus, Proficiency in Excel functions, Pivot Tables and reports, Basic understanding of electronic records management rules, Participates in projects and communicates and interacts with internal customers, Practical experience with desktop application software suites. Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable ICON systems. Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies. This includes multilingual applicants for STEM positions. Develop and execute global regulatory strategy for new and/or modified medical devices including for expanded indications for use. Demonstrates awareness of the procedures and decision-making process of relevant Health Authorities. You will collaborate with cross-functional teams, including research and development, clinical operations, FDA, Notified Bodies, etc.) This Jobot Job is hosted by Mark Johnson Are you a fit? WebTodays top 39 Regulatory Affairs Specialist jobs in South Africa. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 12. With a proven track record of delivering high quality talent, managed services, and consulting, we help our clients build high performing teams and drive long-term value. HHS Recruitment Information Webinar Part 1: Join Americas Premier Healthcare Agency! Featuring HHS Operating Division (OpDiv) Representatives-Providing an overview of OpDiv missions, mission critical occupations and recruitment efforts and initiatives related to diversity, equity, inclusion and accessibility. Become a part of the Department that touches the lives of every American! Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. A regulatory affairs specialist is often employed or usually works in biotechnology, pharmaceutical, and medical device companies. Job Description Contact | Directions | Map We are dedicated to our employees continued growth and development, and we celebrate alongside you as you accomplish great things. The Regulatory Affairs Specialist will be responsible for providing regulatory support to ongoing clinical research trials. Salaries. This Jobot Job is hosted by Mark Johnson. Never give out personal financial information. He/she also has to strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs. The site is secure. WebRegulatory Affairs Specialist I job at Abbott Laboratories | Abbott Careers PLAN FOR SUCCESS CAREER OPPORTUNITIES Our business encompasses many different functions and capabilities, which allows you to explore careers in Prepare complex regulatory submissions and/or presentations (i.e. Job Tittle: Regulatory Affair Specialist Location: 13330 Maycrest Way, Richmond, B.C, V6V 2J7 WebJob details. New Regulatory Affairs Specialist jobs added daily. Job specializations: Learn more about jobs at Stryker. Free pharmaceutical job search site: Senior Regulatory Affairs Specialist job in Harrisonburg Virginia, USA. The .gov means its official.Federal government websites often end in .gov or .mil. Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. WebAs a Regulatory Affairs Specialist you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 13. Regulatory Affairs Specialist - FDA Submissions, Regulatory Affairs Specialist / Senior Specialist, SR. Regulatory Affairs Specialist - HYBRID, Specialist, Regulatory Affairs, Human Factors, See who Mindlance has hired for this role. 14. Each client relationship is grounded in our Piper Engagement Process (PEP), which delivers measurable results and a predictable hiring experience for both clients and candidates. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems. Necessary cookies are absolutely essential for the website to function properly. You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. Cambridge, United Kingdom. Before sharing sensitive information, make sure you're on a federal government site. What You Will DoAs the Staff Regulatory Affairs Specialist, you will be Regulatory Lead for the General Surgery portfolio on new product development teams within the Endoscopy Business. He/she should also possess ability to pay particular attention to details, excellent organizational skills, good project management skills, proficiency and familiarity with databases. Get Our Newsletter, U.S. office: Completes and maintains regulatory approvals and clearances of assigned products. Square Ambiorix 7 One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. You also have the option to opt-out of these cookies. ORA has an ongoing need for qualified individuals with backgrounds in health-related sciences, regulatory policy, and information technology. Software, (This will open in a new window from which you will be automatically redirected to an external site after 5 seconds), https://www.hr.upenn.edu/PennHR/benefits-pay, https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Regulatory-Affairs-Specialist--Remote-Eligible--Abramson-Cancer-Center-_JR00067798. Good time management skills, as a regulatory affairs specialist, must be able to work effectively in a demanding environment where strict timelines and protocols must be met, Proficiency and familiarity with databases or other information management tools, since regulatory affairs specialists frequently work on managing and documenting information, Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities, Well-developed analytical skills and the ability to pay particular attention to details, Well-developed written and oral communication and interpersonal skills to frequently work with other employees and team members, and also advise others on compliance and regulatory matters. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. General understanding of regulations applicable to the conduct of clinical trials. You will be expected to bring your experience as a seasoned regulatory professional to your interactions within our Divisional Regulatory organization and regulatory agencies/notified bodies. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. WebJob details Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company! WebEmployer est. Find job postings in CA, NY, NYC, NJ, TX, FL, MI, OH, IL, PA, GA, MA, WA, UT, CO, AZ, SF Bay Area, LA County, USA, UAE, SA, North America, abroad. What is the difference between a CRA and In-house CRA? What would it look like to wake up every day feeling happy and fulfilled? Growth Planning and Performance Excellence is an Collaborate with PI and on-site monitors in regards to new protocols, amendments, and continual review updates. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? Full-time. Do you want to be notified every time a job like this gets added? This article is also useful to individuals interested in the regulatory affairs specialist career to increase their knowledge of the duties associated with the role. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Job Description Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. WebApply JOB DETAILS LOCATION Bethesda, MD POSTED 1 day ago Piper Clinical Solutions is currently seeking a Regulatory Affairs Specialist to support a Clinical Research Organization (CRO) in the area of Bethesda, MD. Companies. Click the link in the email we sent to to verify your email address and activate your job alert. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Regulatory Affairs Specialist Job Description, Key Duties and Responsibilities. By continuing to use this site, you are giving your consent to cookies being used. Collaborative partners. Ensure compliance to global processes and regulations. Create a job alert and receive personalized job recommendations straight to your inbox. Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either changes in the business or regulatory requirements. Subscribe to jobs like this! Dedicated achievers. Listing for: Bausch + Lomb. and for any related communications. The primary goal of this site is to highlight open FDA positions, share important tips for becoming a hireable candidate, information about our various centers, and insights into what working at FDA looks like for various employees. They may also work in the government or law. WebResponsibilities for the Regulatory Affairs Specialist: Prepare regulatory documentation, track regulatory activities, and ensure accuracy. Powered by Madgex Job You can unsubscribe from these emails at any time. Regulatory affairs specialist salary: The average annual salary for a regulatory affairs specialist is $68,294. Good time and project management skills with the ability to multi-task. Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company! They are often employed by medical, pharmaceutical, and biotechnology companies. ICON plc is a world-leading healthcare intelligence and clinical research organisation. pre-submissions, IDEs, 510(k)s, Technical Files, etc.) For Employers. WebJob details. The Regulatory Affairs Specialist II provides leadership in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants and the like to obtain and maintain Additional experience may be considered in lieu of a degree, Minimum of 3 years of relevant experience, Demonstrates critical thinking skills and the ability to apply this to daily workload decisions. Individual pay is based on skills, experience, and other relevant factors.About StrykerStryker is one of the worlds leading medical technology companies and, together with our customers, is driven to make healthcare better.The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Below, please find related information to help you with your job search. Job in Leesburg - Loudoun County - VA Virginia - USA , 22075. Web76 Regulatory Affairs Specialist jobs available in California on Indeed.com. More information is available at www.stryker.comWe are currently seekinga Staff Regulatory Affairs Specialistto join ourEndoscopy Divisionbased in San Jose, CA or remotely anywhere within the United States.Who We Want. Washington, DC 20037 Please, continue reading to learn more about the regulatory affairs specialist career: A regulatory affairs specialist is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations. WebGet notified about new Regulatory Affairs Specialist jobs in Alameda, CA. Careers. Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment. 1000 Brussels Leverage your professional network, and get hired. Suzaita's story - an insight into working in Clinical Research, Building DIB into the fabric of our organizational culture. Prepare regulatory documentation, track regulatory activities, and ensure accuracy, Collaborate with PI and on-site monitors in regards to new protocols, amendments, and continual review updates, Ability to prepare, edit, and distribute templates, work instructions, SOPs, checklists, etc, Preparation of investigator/pharmaceutical company meeting minutes, Maintain Trial Master File and other electronic filing systems, Other administrative regulator support as assigned, 1 (one) year of experience with FDA Submissions (IND and IRB submissions a plus), Masters Degree in Public Health, Life Sciences, or related field or Ph.D preferred, Salary range: $75,000 - $95,000 (based on relevant experience), Benefits include: Health, Dental & Vision Insurance, 401k. Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. It also presents the major requirements recruiters may want you to meet to be hired as a regulatory affairs specialist. Create submission content plan to feed in the DCN for CS portal maintenance as well as creating CMC information records to capture new submitted and approved CMC updates for all impacted fields in the RIM tool. Once your application has been received, a confirmation email will be sent to your email. It also includes determining the types of regulatory submissions or internal documentation that are needed in situations like labeling changes or proposed device changes. WebRegulatory affairs jobs include: regulatory affairs specialist, manager or director, design and graphics labeling specialist, labeling project manager, clinical research associate, Ability to understand and explain detailed regulatory requirements, with particular proficiency in the US, Canada, and EU, and comply with constantly changing Analytical problem solvers. Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU MDR 2017/745. Our Value:With a focus on understanding the needs and objectives of each enterprise we serve, Piper augments its staffing solutions with program management innovations to help teams reach maximum performance and deliver business results. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. 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Early talent programs are designed to provide participants with opportunities to gain valuable experience, develop their skills, and build relationships with experienced leaders within the organization. See our, Options: 1330, 1717, 2343, 262, 2375, 2201, ICON Full Service & Global Business Services, Early Clinical and Bioanalytical Solutions, Regulatory Affairs/ Drug Safety/ Quality Assurance. In this role, a typical day might include the following: Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply, Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes, Provides regulatory submission updates to cross-functional groups, as needed to support a stable clinical supply position, Maintains regulatory submission forms to support regulatory release and QP certification, Provides updates to management that need to be communicated to Regenerons CROs to maintain that submission requirements are being met and provide consistent metrics and feedback on CTA processes and procedures, Works within the procedures and systems for enhanced tracking of submission packages and approval status, You have a strong understanding of quality principals in a regulated manufacturing environment, You bring strong communication and program management skills, You can implement improvements to processes while having scope changes occur during the project, To be considered for the opportunity, we expect you to have at 1+ years of experience in the life science industry with a focus in biopharmaceutical manufacturing or regulatory or compliance related activities with a bachelor's degree in chemistry, Biology or related field. Click the CTA below! Contact | Directions | Map 2121 K St. We provide reasonable accommodation to qualified individuals with disabilities. Direct message the job poster from Mindlance. All rights reserved. At ORA, you make a difference in protecting the health of the American people. This category only includes cookies that ensures basic functionalities and security features of the website. Part 2 will feature representatives from HHS Office of the Secretary Staffing Divisions (StaffDivs) who will provide an overview of the mission of their StaffDiv, identify mission critical occupations and discuss StaffDiv DEIA recruitment efforts and implementation initiatives. HHS Recruitment Information Webinar Part 3: How to Obtain Your Dream Job in Federal Government presentations from representatives on Disabled Veterans Affirmative Action Program (DVAAP), How to Apply for a Federal Job and Get Involved with Training and others. This role is a senior member of the Regulatory staff, providing Regulatory expertise to cross-functional team members and mentoring junior Regulatory specialists.
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