Regulatory Affairs Specialist jobs in Rocky Mount, 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...
- 15 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...
- 24 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...
- 12 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...
- 4 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...
- 19 Days Ago
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0 Regulatory Affairs Specialist jobs found in Rocky Mount, NC area
Surgical Technologist
- Unc Health Care Systems
-
Rocky Mount, NC
- Description Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the...
- 4/19/2024 12:00:00 AM
Clinical Research Billing Coverage Analyst
- Vidant Health
-
Greenville, NC
- Job Description ECU Health About ECU Health ECU Health is a mission-driven, 1,708-bed academic health care system servin...
- 4/18/2024 12:00:00 AM
RN - Clinical Manager
- Gentiva Hospice
-
Rocky Mount, NC
- Our Company: Gentiva Hospice is a member of the Gentiva family an industry leader in hospice, palliative, home health, a...
- 4/18/2024 12:00:00 AM
Licensed Practical Nurse - LPN - LVN
- Fresenius Medical Care
-
Rocky Mount, NC
- Description Provide your personal attention and kindness, professional insight, and a generosity of spirit. Offer expert...
- 4/18/2024 12:00:00 AM
Nurse Practitioner (Primary Care Med)
- Eventus WholeHealth
-
Rocky Mount, NC
- Job Description Job Description Position Summary: Eventus WholeHealth delivers an integrated model of care to adults who...
- 4/18/2024 12:00:00 AM
Phlebotomist
- Octapharma
-
Rocky Mount, NC
- Want to Expand your career-development potential, your ability to help donors and patients, and your access to professio...
- 4/17/2024 12:00:00 AM
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
RN Clinical Manager, Home Health - Rocky Mount, NC
- Humana
-
Rocky Mount, NC
- Become a part of our caring community and help us put health first Work Schedule: Full-time/40 Hours Position Type: On-s...
- 4/15/2024 12:00:00 AM
About Rocky Mount, North Carolina
Rocky Mount is a city in Edgecombe and Nash counties in the Atlantic coastal plain region of the U.S. state of North Carolina. Although it was not formally incorporated until February 28, 1907, the North Carolina community that became the city of Rocky Mount dates from the beginning of the 19th century. The first post office in the area opened in 1816. The city's population was 57,685 at the 2010 census, with an estimated population of 56,325 in 2014. Rocky Mount has received the All-America City Award from the National Civic League two times, in 1969 and 1999.
Rocky Mount is the principal cit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,524 to $98,533
Rocky Mount, 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