Regulatory Affairs Specialist jobs in Raleigh, 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 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...
- 1 Month 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...
- 19 Days Ago
Director, Regulatory Affairs
- Azurity Pharmaceuticals - US
-
Raleigh, NC
FULL_TIME
- Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization. Ability to provide Advertising/...
- Just Posted
Regulatory Affairs Assistant
- Atlantic Medical Management
-
Cary, NC
FULL_TIME
- Summary:Atlantic Medical Management (AMM) is seeking an Regulatory Affairs Assistant. AMM is a corporate medical management firm that is dedicated to improving patient care. The Regulatory Affairs/Sup...
- 1 Day Ago
Director of Regulatory Affairs
- University of North Carolina at Chapel Hill
-
Chapel Hill, NC
FULL_TIME
- Posting Information Department Globl Hlth and Infect Disease-427801 Career Area Research Professionals Posting Open Date 04/22/2024 Application Deadline 05/13/2024 Open Until Filled No Position Type P...
- 1 Day Ago
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0 Regulatory Affairs Specialist jobs found in Raleigh, NC area
Regulatory Affairs Specialist
- PSI CRO
-
Durham, NC
- Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a ...
- 4/26/2024 12:00:00 AM
R&D Project Manager
- K-recruiting Life Sciences
-
Raleigh, NC
- R&D Project Manager (M/F/D) Tasks Develop comprehensive project plans and timelines specifically tailored to electromech...
- 4/26/2024 12:00:00 AM
Operational Risk Analyst / Compliance Analyst ( LOCALS ONLY ) --- Remote & Twice a week Onsite
- Zillion Technologies, Inc.
-
Raleigh, NC
- THIS IS A DIRECT BANKING CLIENT REQUIREMENT ! Those authorized to work without sponsorship are encouraged to apply pleas...
- 4/26/2024 12:00:00 AM
Director of Regulatory Affairs
- The Judge Group
-
Raleigh, NC
- ** This role is in Raleigh, NC. We are considering candidates open to relocation. It is onsite 3 days/remote 2 days/wk**...
- 4/24/2024 12:00:00 AM
Regulatory Affairs Specialist (Relo Available)
- Planet Pharma
-
Durham, NC
- *Relocation Assistance Available* Responsibilities: Responsible for liaising with project teams to procure documents nec...
- 4/22/2024 12:00:00 AM
R&D Project Manager
- K-Recruiting Life Sciences
-
Raleigh, NC
- R&D Project Manager (M/F/D) Tasks: Develop comprehensive project plans and timelines specifically tailored to electromec...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist
- PSI
-
Durham, NC
- Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a ...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist
- Loparex LLC
-
Cary, NC
- Regulatory Affairs Specialist The Regulatory Affairs Specialist ensures product safety and legal compliance regarding gl...
- 4/22/2024 12:00:00 AM
About Raleigh, North Carolina
According to the United States Census Bureau, Raleigh occupies a total area of 144.0 square miles (373.0 km2), of which 142 square miles (369 km2) is land and 0.97 square miles (2.5 km2), or 0.76%, is covered by water. The Neuse River flows through the northeast end of the city.
Raleigh is located in the northeast central region of North Carolina, where the Piedmont and Atlantic Coastal Plain regions meet. This area is known as the "fall line" because it marks the elevation inland at which waterfalls begin to appear in creeks and rivers. As a result, most of Raleigh features gently rolling hil...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,055 to $99,246
Raleigh, 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