Regulatory Affairs Specialist jobs in Utica, NY

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)

1
Principal Regulatory Affairs Consultant
  • 1010 Parexel International, LLC
  • Maryland, NY FULL_TIME
  • When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel’s Regulatory Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing! We currently have a home-based opening on our Strategic Regulatory Compliance Team for a an experienced GMP Compliance Expert to join the team as a Principal Consultant. This is an incredible opportunity to assist pharmaceutical and biopharmaceutical companies in driving quality; help our clients manage and prepare for FDA GMP inspections and manage post inspection activities; and work alongside some of the best and most experienced regulatory compliance professionals. A truly phenomenal opportunity to apply your expertise while continuing to develop your career! A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization. To be successful a Principal Consultant will have specialized experience in the following: Pre-approval and pre-licensing sterile inspection experience Experience conducting inspections which have resulted in FDA-483 Inspectional Observations and subsequent OAIs and/or Warning Letters Experience in the following areas is a plus: Preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters Providing on-site guidance during FDA inspections Preparation for Discussion of Regulatory Compliance Matters with FDA Playing an active role in Compliance Remediation strategy and implementation Conducting specialized GMP training Education: PhD in a in a scientific discipline or other advanced degree or equivalent in engineering is highly preferred with 12 years of GMP experience. Previous experience conducting sterile facility inspections is required. Knowledge and Experience: Previous Industry experience in Quality and/or Compliance or previous experience as a Consumer Safety Officer with a regulatory agency (such as FDA, MHRA) is strongly preferred. Strong regulatory knowledge is required. Skills: High-level consulting skills Critical thinking and problem-solving skills Project leadership and management knowledge Excellent interpersonal and intercultural communication skills, both written and verbal Meticulous attention to detail and the ability to spot issues. Client-focused approach to work Results orientation Teamwork and collaboration skills Proficiency in local language and extensive working knowledge of the English language Proactive Networking Business acumen and analysis Self-confidence and control Up to 70% Domestic and International Travel Required EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
  • 17 Days Ago

S
Senior Regulatory Specialist
  • Stantec
  • Maryland, NY FULL_TIME
  • Senior Regulatory Specialist - ( 240000FL ) Description Grounded in safety, quality, and ethics, our experts lead their fields and guide our work with rigor, a creative spirit, and vision for growth. ...
  • 1 Month Ago

1
Vice President, Technical / Clinical Regulatory Affairs SME - Oncology
  • 1010 Parexel International, LLC
  • Maryland, NY FULL_TIME
  • When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market acces...
  • 17 Days Ago

S
Academic Affairs Financial Operations Specialist - SUNY Oneonta
  • SUNY Oneonta
  • Oneonta, NY FULL_TIME
  • Location: Oneonta, NY Category: Professional Posted On: Wed Jan 10 2024 Job Description: At SUNY Oneonta, we nurture a community where students grow intellectually, thrive socially, and live purposefu...
  • 14 Days Ago

V
Principal Business Consultant - R&D - Regulatory (Remote)
  • Veeva Systems
  • Copenhagen, NY FULL_TIME
  • Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Th...
  • Just Posted

N
Senior IT Business Analyst, Regulatory Systems
  • Novavax
  • Maryland, NY FULL_TIME
  • If you find science, speed, and success exhilarating, you have come to the right place.Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of...
  • 16 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Regulatory Affairs Specialist jobs found in Utica, NY area

C
Evening Shift Clinical Laboratory Technologist
  • Clinical Management Consultants
  • Utica, NY
  • An established critical access hospital located in mid-state New York is currently searching for an experienced Evening ...
  • 3/28/2024 12:00:00 AM

T
Travel Speech Language Pathologist - $2,488 per week
  • TRS Healthcare
  • Utica, NY
  • Focus Staff is seeking a travel Speech Language Pathologist for a travel job in Utica, New York. Job Description & Requi...
  • 3/28/2024 12:00:00 AM

R
Quality Compliance Manager (Onsite)
  • Raytheon Technologies
  • Rome, NY
  • Date Posted: 2024-01-26 Country: United States of America Location: HNY02: Engine Comp (Power) - Rome 104 Otis Street, R...
  • 3/27/2024 12:00:00 AM

M
Registered Nurse - Med/Surg - Full Time - Nights
  • Mohawk Valley Health System
  • Utica, NY
  • Registered Nurse - Med/Surg - Full Time - Nights Department: NURS MED/SURG 6TH Job Details Req Id 59264 Department NURS ...
  • 3/27/2024 12:00:00 AM

I
Registered Nurse
  • ican inc
  • Utica, NY
  • As a key member of the agencys healthcare team, the RN plays a critical role in delivering exceptional care and support ...
  • 3/27/2024 12:00:00 AM

E
Compliance Specialist
  • Express Employment Professionals
  • Utica, NY
  • Job Description Job Description Premier company in Utica is seeking a Compliance Specialist to join their team and be re...
  • 3/26/2024 12:00:00 AM

D
SIU Investigator
  • Delta Group
  • Utica, NY
  • Job Description Job Description Salary: $30 - $40 an hour DOE Delta Group is a privately held, woman-owned, national inv...
  • 3/26/2024 12:00:00 AM

A
Clinician / Licensed Mental Health Therapist - LMSW/LMHC/LMFT
  • A dynamic organization dedicated to improving the lives of individuals and families.
  • Utica, NY
  • Job Description Job Description Competitive Salary and Excellent Benefits + $5,000 Sign-On Bonus! A leading provider of ...
  • 3/24/2024 12:00:00 AM

Utica (/ˈjuːtɪkə/ (listen)) is a city in the Mohawk Valley and the county seat of Oneida County, New York, United States. The tenth-most-populous city in New York, its population was 62,235 in the 2010 U.S. census. Located on the Mohawk River at the foot of the Adirondack Mountains, Utica is approximately 95 miles (153 kilometers) northwest of Albany, 55 mi (89 km) east of Syracuse and 240 miles (386 kilometers) northwest of New York City . Utica and the nearby city of Rome anchor the Utica–Rome Metropolitan Statistical Area, which comprises all of Oneida and Herkimer counties. Formerly a rive...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,701 to $98,769
Utica, New York area prices
were up 1.5% from a year ago

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