Regulatory Affairs Specialist jobs in Missouri
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
Sr. Regulatory Affairs Specialist
- Fladger Associates
-
Joseph, MO
CONTRACTOR
-
St Joseph
Contract Duration: 8-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities- Excellent employment opportunity for a Sr. Regulatory Affairs Specialist in the St Joseph, MO area.
- Support all regulatory activities required by Federal, State, local, and International laws, as well as internal policies for continued manufacturing, distribution, and sales of veterinary biologics.
- In a team environment, to provide logistical and tactical regulatory expertise to internal business partners and stakeholders.
- To serve as main point of contact for Industrial Operations, Commercial Operations, and Research & Development (R&D) for regulatory aspects of the veterinary biologics portfolio supply chain defense and life cycle management (LCM).
- To determine appropriate regulatory requirements, commitments and actions required to support maintenance and defense of existing licensed products and manufacturing sites.
- To actively participate with non-regulatory team members in integrating the regulatory perspective in project teams related to new product development or LCM.
- To remain current with regard to domestic and international laws, regulations, guidelines and/or policy that may impact Animal Health veterinary biologics and recommend appropriate action to protect the Company's interests.
- In accordance with applicable regulatory requirements and the registration plans, create and maintain abbreviated files for international regulatory submission and provides technical regulatory support to assist timely and efficient registration in all target markets.
- Support regulatory compliance of licensed biological products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, renewals, and geographic extension in close collaboration with Industrial Operations, Quality Assurance (QA), R&D, Pharmacovigilance (PV), Business Operations, Legal, and others.
- Support responses to regulatory inspections and government inquiries (domestic and international)
- Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations
- Provide regulatory expertise and advice, as appropriate, to other functions or interdisciplinary project teams (in-line product management, launch teams, etc.)
- Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs.
- Maintain work instructions and tools (records, schedules, reports, database, etc.) for timely and efficient management of regulatory activities.
- Manage and provide oversight for assembly, review, formatting, circulation, approval, and submission of Outlines of Production, Special Outlines, and facility documents to the Center for Veterinary Biologics (CVB) to support compliance and variations
- Support organization, archiving, and retrieval of regulatory documents and correspondence
- Help to assemble and provide final QA review for electronic submissions to government agencies through government portal(s) including updating documents to required templates and compliance with electronic record keeping
- Maintain regulatory databases, activities charting, and government submission and response tracking
- Master's Degree from an accredited institution, preferably in area of Science, with 1 year of related industry or Regulatory experience OR
- Bachelor's Degree from an accredited institution, preferably in area of Science, with a minimum of two (2) years previous relevant industry or Regulatory affairs experience.
- In lieu of either degree, 8 years of relevant industry experience and 3 years of relevant regulatory experience.
- Must have regulatory knowledge and expertise.
- Ensures compliance with Federal and State regulations of >120 licensed products, 3 major US manufacturing sites, and >80 countries products are exported to.
- Requires minimal supervision.
- Experience in the Pharmaceutical, Biologics and/or related industries or disciplines dealing with US Local, State, and Federal regulatory issues related to in particular those associated with product development, licensure, and maintenance, licensed manufacturing facilities and related industry matters.
- Experience interacting with USDA or other government agencies preferred.
- Excellent communication (verbal and written), negotiation, organizational, and teamwork skills
- High level of computer skills, including proficiency in Microsoft Word, Excel, Adobe Acrobat
- Required Skills: GOVERNMENT CONTRACT, COMPLIANCE REGULATIONS, REGULATORY AFFAIRS
- 4 Days Ago
Regulatory Affairs Specialist
- Astrix
-
Joseph, MO
FULL_TIME
- Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for...
- 4 Days Ago
Regulatory Affairs Operations Specialist
- Cynet Systems
-
Joseph, MO
CONTRACTOR
- Job Description: With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establ...
- 5 Days Ago
Regulatory Affairs Specialist
- Ensign-Bickford Industries
-
Charles, MO
FULL_TIME
- This job offer is not available in your country. This opportunity is located within our AFB International business, the global science and technology leader in pet food palatability. We develop and pr...
- 11 Days Ago
Regulatory Affairs Specialist
- AFB International
-
Charles, MO
FULL_TIME
- We make pet food taste great! For over 30 years, AFB International has been providing pet food solutions that enrich the lives of pets and their people. Our palatants are specially designed to make pe...
- 12 Days Ago
US Regulatory Affairs Operations Specialist
- LanceSoft, Inc.
-
Joseph, MO
FULL_TIME
- Note requirement to be in the office 2-3 days a week.Remote eligible: NoFull time or part time: Part timeShift: Anywhere between 8 am to 5 pm, Monday-Friday as scheduledHours: 20 hours per weekAny pos...
- 2 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Experis
-
Maplewood, MN
- Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About Missouri
Missouri is landlocked and borders eight different states as does its neighbor, Tennessee. No state in the U.S. touches more than eight. Missouri is bounded by Iowa on the north; by Illinois, Kentucky, and Tennessee across the Mississippi River on the east; on the south by Arkansas; and by Oklahoma, Kansas, and Nebraska (the last across the Missouri River) on the west. Whereas the northern and southern boundaries are straight lines, the Missouri Bootheel protrudes southerly into Arkansas. The two largest rivers are the Mississippi (which defines the eastern boundary of the state) and the Misso...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,757 to $97,503
Most Popular Cities in Missouri for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019