Phd In Quality Assurance And Regulatory Affairs – Regulatory experts assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products and related materials. They are often employed by pharmaceutical, biotechnology and medical device companies. They can also work in government or law. The duties and responsibilities of regulatory specialists have expanded in recent years as a result of acquisitions and restructuring of companies, global globalization of markets and ever-evolving regulations. Typically, people in these roles work in a regulatory affairs office where they work on document preparation, information management, file maintenance and task coordination in ‘various departments. Part of their strategic direction is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market and costs. The Office of Regulatory Affairs is a dynamic work environment where communication with employees at all levels in the organization is extremely important.
Regulatory experts must understand all aspects of product development, including research, clinical trials, manufacturing methods, regulations and approval processes. Assist in reviewing product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. They often advise project teams on issues such as pre-market regulatory requirements, export and labeling requirements, or compliance issues in clinical studies. In addition, they determine the types of regulatory filings or internal documentation required in situations such as proposed device changes or labeling changes.
Phd In Quality Assurance And Regulatory Affairs
A variety of job titles may be used in this profession, including Clinical Quality Assurance Associate or Specialist, Drug Control Affairs Specialist, Product Safety Specialist, Coordinator or Specialist of Quality Assurance Documentation, Quality Assurance/Regulatory Specialist (QA/RA Specialist), Regulatory Affairs Analyst, and regulatory affairs partner. Some typical job tasks include:
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Regulatory positions have increasing levels of responsibility and more senior people are usually given the titles of manager or director. Jobs in this field are expected to grow due to expanding government regulation in the health and pharmaceutical industries.
Regulatory Specialists must be able to work in a demanding environment where strict schedules and protocols must be met. They often work on information management and documentation, and must be proficient in working with databases and other information management tools. Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent organizational, analytical, project management and communication skills. They often work with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions are full-time. Some may work in contractor or consultant roles related to a specific product. Others may be long-term roles covering a wider range of products. Because they need to stay up-to-date in their area of expertise, attendance at relevant professional conferences or training events is common.
Entry-level regulatory affairs professionals have a bachelor’s degree. Typical majors include biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine and engineering. Courses in law, marketing, business and statistics are also useful. Those who advance in the profession often have a master’s degree (eg in business administration, clinical research studies, engineering or life sciences) or a terminal degree (eg PhD, MD or PharmD). Promotion may require certification, for example through Regulatory Affairs Certification (RAC). Office of Regulatory Affairs and Quality Updates from the Office of Regulatory Affairs and Quality (ORAQ): Regulatory Review Requirements Changes to ORAQ Cost Submission Processes Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality
ORAQ Mission ORAQ offers regulatory support and quality assurance in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. Our goal is to provide the Duke community with the tools, training and support necessary to navigate the complex regulatory pathways that accompany translational research. We aim to do this by providing support in the following areas: Early regulatory strategy development Preclinical testing and GMP manufacturing Regulatory submissions and maintenance FDA meetings and inspections Education and training Outreach and collaboration Basic FDA requirements for clinical trials ( IND/IDE/ITP); dealing with small molecule drugs, pharmaceuticals, biologicals, cell therapy, devices, in vitro diagnostics, mobile medical applications,
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Office of Regulatory Affairs and Quality Regulatory Affairs Current Numbers: Over 140 Active INDs and 6 Active IDEs Over 155 Approved Applications (ITPs, ODDs, DMFs) Approved BLA (Marketing Application) SOM Concerns: 1/3-2/3 of Regulatory Submissions No review Found some post hoc errors that put IND/IDE holders at risk or cause delays Challenge teams to keep up with the changing regulatory landscape
Office of Regulatory Affairs and Quality New Institutional Review Requirements Previous structure: Use of ORAK for regulatory support is optional. Current Model: All FDA regulatory submissions related to a clinical trial (IND/IDE/ITP) will be required to go through ORAQ for review.
Office of Regulatory Affairs and Quality New Institutional Review Requirements The initial application and/or amendment may still be drafted by the research team, but the submission must be reviewed by ORAQ before being sent to the FDA. The submission can be prepared and submitted by the research team, but ORAQ can offer support for this work to assist research teams with this workload. ORAQ must obtain a final copy of all submissions and keep in a central repository. Research staff may still serve as the secondary FDA contact, but all official FDA correspondence (requests for information, etc.) must be shared with ORAQ.
Office of Regulatory Affairs and Quality New Requirements for Institutional Review Timeline: Requirements are being implemented in initial/original application review stages beginning November 1, 2019. Start collect copies of all submissions at this stage. Get information about the weight of the submission and evaluate the resources of ORAQ. The review of additional submissions, such as additions, reports, corrections, etc., will be done gradually over the course of a year. We will notify sponsors and research support staff directly when new review requirements come into effect. Current information will also be available on our website.
How To Start A Career In Regulatory Affairs?
Office of Regulatory Affairs and Quality Changes in ORAQ Costs Previous structure: ORAQ services were not a cost to the clinical research community at Duke University. Current Model: ORAQ has moved to a cost reimbursement model, whereby unpaid effort is charged back to academic departments or funding codes on a monthly basis. This change was communicated by the SOM leadership to the presidents of the departments at the August 2019 meeting.
ORAQ Expenses The ORAQ service request form contains fields for department self-report or fund code for reimbursement. Collaborative projects will be required to select a primary department or fund code for billing. This determination is made by the study team or by the faculty involved in the project. Research teams should work with ORAQ to estimate project costs and plan for those costs in grant applications.
Office of Regulatory Affairs and Quality New Submission Processes Previous structure: All drug/biological submissions sent to CDER or CBER for investigational INDs (ie, non-commercial INDs) are sent in triplicate and sent to FedEx overnight. Current Model: All drug/biologic submissions sent to CDER or CBER for an investigational IND are submitted electronically through FDA’s Electronic Submissions Gateway in a non-eCTD format.
Office of Regulatory Affairs and Quality New Submission Processes Benefits: Faster Acceptance Times – Same Day Submission Less Onerous Preparation More Cost Effective Non-eCTD Submissions Can Switch Back to Paper If Faculty Ever leaving Duke Important Changes: ORAQ will provide academic staff with an electronic copy (fused PDF ) of the final submission for record keeping. Hard copies will no longer be supplied.
What Makes Regulatory Affairs People Love What They Do?
Office of Regulatory Affairs and Quality Additional Information Newsletter Information Website Notices Notices to Current Regulatory Sponsors Research Support Offices Research Presentation Wednesday (2/26/2020)
Duke University – Hock Plaza 2424 Erwin Road, 4th Floor Durham, NC 27705 Website: Summary information and FAQ on recent changes Link to service and budget request forms including new and updated regulatory model documents Contact information for our staff Registration/request for events Program speaker training : Contact For questions:
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Project manager recruitment for a medical technology and device organization. This position is on a permanent basis and is located in Freiburg.
Jagadguru Sri Shivarathreeshwara University
Recruitment of an assistant project manager for a medical technology and device organization. This position is on a permanent basis and is located in Freiburg.
Have you ever thought of working in regulatory affairs? A career in regulatory affairs can provide rewarding and exciting opportunities, but it can be a challenging field to break into as most roles require prior experience. Here’s our advice on how to get your feet on the ladder and start your career in regulatory affairs.
Regulatory affairs play a vital role in any life sciences company, as they ensure the safe and effective production of healthcare products, including pharmaceuticals and medical devices. The companies responsible for the creation, production and marketing of medical products have the duty to confirm that the products they produce are fit for purpose and make an important contribution to health and well-being.
Under the responsibility of a regulatory affairs professional
Pdf) Opportunities And Challenges To Implementing Quality By Design Approach In Generic Drug Development
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