Regulatory Affairs Specialist jobs in Wilson, NC
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Regulatory Affairs Specialist
- PSI CRO
-
Durham, NC
FULL_TIME
- Company DescriptionPSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionJoin our team of experts in regulatory and ethics submissions of clinical studies! You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.This is a hybrid role which includes remote and in-office work. Your role:Responsible for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions.Responsible for the preparation of regulatory and ethics committee submission dossiers, including applications for import and export licenses, where applicable.Responsible for reviewing translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).Primary responsibility for tracking regulatory project documentation flow and progress reporting.Supervised responsibility for maintaining a database of regulatory requirements.Primary or secondary responsibility for registration/marketing authorization projects and renewals (where applicable). Responsible for the compilation and review of Investigational New Drug Applications (INDs).Primary or secondary contact person for ethics committees and regulatory authorities, project teams on all regulatory-related issues, and co-contractors, subcontractors, and third- party vendors (regulatory issues).Secondary responsibility for the development and update, if necessary, of project planning documents, including project timelines (regulatory aspects) and safety management plan, where applicable (in cooperation with Medical Affairs).Responsible for review of investigational product release-enabling documents.Primary or secondary responsibility for training company employees in regulatory practices. Responsible for ensuring accurate and time-bound reporting of safety issues to authorities and reviewing incoming safety reports for completeness.Provide assistance to business development at client presentations, bid defense meetings, and the like in various regulatory aspects (at the discretion of Senior Regulatory Affairs staff).Please note that the official PSI CRO title will be: Regulatory OfficerQualificationsMust have a College/University degree or an equivalent combination of education, training and experience.Must have 3 years of hands-on relevant Regulatory Affairs experience.Experience with the review, maintenance, and compilation of the IND lifecycle and submissions. Experience interacting with and acting as the liaison with the FDA/Sponsor/ etc.Prior experience with Health Canada is a plus. Proficiency in MS Office applications.Detail-oriented, ability to learn, plan and work in a dynamic team environment.Must have excellent communication, collaboration, and problem-solving skills.Additional InformationIf you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
- 1 Month Ago
Regulatory Affairs Specialist, Rare Diseases
- Chiesi Farmaceutici
-
Cary, NC
FULL_TIME
- Date: Apr 1, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US About us Based in Parma...
- 12 Days Ago
Regulatory Affairs Senior Specialist - Medical Devices
- Career Opportunities at Merz North America
-
Raleigh, NC
FULL_TIME
- The Regulatory Affairs Senior Specialist - Medical Devices coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with...
- 22 Days Ago
Manager, Regulatory Affairs Labeling
- HUMACYTE GLOBAL INC
-
Durham, NC
FULL_TIME
- Manager, Regulatory Affairs Labeling Position Profile Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally impla...
- 10 Days Ago
Associate Director, Regulatory Affairs
- Mayne Pharma
-
Raleigh, NC
FULL_TIME
- Position Overview: This position reports to the Vice President, Regulatory Affairs and Quality and has the overall responsibility for managing pre and post marketing regulatory activities for all comp...
- 2 Days Ago
Director of Regulatory Affairs
- Merz Therapeutics
-
Raleigh, NC
FULL_TIME
- ** This role is in Raleigh, NC. We are considering candidates open to relocation. It is onsite 3 days/remote 2 days/wk** Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take...
- 17 Days Ago
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0 Regulatory Affairs Specialist jobs found in Wilson, NC area
Financial Care Counselor - DRAH Outpatient Service Access (Float Position)
- Duke Health
-
Rolesville, NC
- PRMO Established in 2001, Patient Revenue Management Organization (PRMO) is a fully integrated, centralized revenue cycl...
- 4/16/2024 12:00:00 AM
Financial Care Counselor - DRAH Outpatient Service Access (Float Position)
- Duke Health
-
Raleigh, NC
- PRMO Established in 2001, Patient Revenue Management Organization (PRMO) is a fully integrated, centralized revenue cycl...
- 4/16/2024 12:00:00 AM
Executive Chef (Healthcare)
- Hospital Housekeeping Systems
-
Wilson, NC
- Executive Chef, Healthcare Food Service DLP Wilson Medical Center Salary $63,000.00 Support the healing journey for pati...
- 4/16/2024 12:00:00 AM
Backend Subject Matter Expert (SME) - Assistant Vice President
- Deutsche Bank
-
Cary, NC
- Job Title: Backend Subject Matter Expert (SME) Corporate Title: Assistant Vice President Location: Cary, NC Who we are I...
- 4/15/2024 12:00:00 AM
Senior Manager – Accounting & Statutory Reporting
- Genworth
-
Raleigh, NC
- At Enact Mortgage Insurance (Nasdaq: ACT), we understand that there’s no place like home. That’s why we bring our deep e...
- 4/15/2024 12:00:00 AM
Director of Regulatory Affairs
- Hiring Now!
-
Raleigh, NC
- ** This role is in Raleigh, NC. We are considering candidates open to relocation. It is onsite 3 days/remote 2 days/wk**...
- 4/14/2024 12:00:00 AM
Senior Manager, Operational Risk Strategy and Regulatory Readiness
- Royal Bank of Canada
-
Raleigh, NC
- Job Summary The Senior Manager, Operational Risk Strategy and Regulatory Readiness will assist in leading the Operationa...
- 4/13/2024 12:00:00 AM
Director of Safety and Risk Management
- FORVIS' Executive Search Practice
-
Raleigh, NC
- Please Note: This position is not for FORVIS LLC. We are working with one of the nation’s top heavy civil contractors wh...
- 4/13/2024 12:00:00 AM
About Wilson, North Carolina
Wilson is a city in and the county seat of Wilson County, North Carolina, United States. Located approximately 40 mi (64 km) east of the capital city of Raleigh, it is served by the interchange of Interstate 95 and U.S. Route 264. Wilson had an estimated population of 49,610 in 2012, according to the Census Bureau.
In the early 21st century, Wilson was ranked as 18th in size among North Carolina’s 500-plus municipalities. From 1990 to 2010, the city population increased by more than 40 percent, primarily due to construction of new subdivisions that attracted many new residents. This has been ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,524 to $98,533
Wilson, North Carolina area prices
were up 1.5% from a year ago
were up 1.5% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020