Regulatory affairs specialist Jobs in St Louis, MO
Last updated: 21 hours ago
The (Contractor) Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications.
Support of regulatory activities including but not limited to : .Plan / ...Show moreLast updated: 30+ days ago
Environmental Regulatory Specialist.The ideal candidate will have a background in one of the natural sciences and experience in planning and coordinating.
Federal Energy Regulatory Commission (FERC)...Show moreLast updated: 30+ days ago
The Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications.Support of regulatory activities including but not limited to : .Plan / author / compil...Show moreLast updated: 30+ days ago
We bring to life a healing ministry through our compassionate care and exceptional service.Join us and discover why Modern Healthcare Magazine named us in its “Top 100 Places to Work.The Senior Acc...Show moreLast updated: 7 days ago
Want a meaningful career where you can make a difference? Edward Jones sounds perfect for you.Words our headquarters associates use when talking about working at Edward Jones.Words that describe wh...Show moreLast updated: 21 hours ago
Louis, Missouri; Chicago, Illinois.Kemper is one of the nation’s leading specialized insurers.Our success is a direct reflection of the talented and diverse people who make a positive difference in...Show moreLast updated: 3 days ago
LouisOur Consumer Affairs unit is looking for individuals to join our team of Bank Examiners in our St.Louis, MO office or Little Rock, AR branch.
Candidates without an examiner commission that have...Show moreLast updated: 30+ days ago
Senior leader to advance BCBSA’s legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of mill...Show moreLast updated: 30+ days ago
SummaryA career within United States National Tax services, will provide you with the opportunity to help our clients gain valuable insight into emerging tax issues and trends, as well helping them...Show moreLast updated: 30+ days ago
This job is responsible for leading large projects and initiatives related to the risk case management and intake activities of Highmark Health in support of a broad range of frameworks and oversig...Show moreLast updated: 30+ days ago
We bring to life a healing ministry through our compassionate care and exceptional service.Join us and discover why Modern Healthcare Magazine named us in its "Top 100 Places to Work.The Senior Acc...Show moreLast updated: 29 days ago
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health.
This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
Additional Information About the Role BJC HealthCare is looking for for a Regulatory Compliance Specialist.This role will have an integral part of ensuring that laws and regulations are being follo...Show moreLast updated: 30+ days ago
(Contractor) Regulatory Affairs Specialist
Curium Live ForwardSt. Louis, MO, United StatesTemporary
Managing Consultant, Environmental Regulatory Specialist (Senior Level)
ERMSt Louis, Missouri$76,000.00–$94,860.00 yearly
Full-time
Midwest Territory Manager - Veterans Affairs
ColoplastSt. Louis, MO, US The Continence Care VA Specialist is responsible for achieving territory sales objectives through selling activities which include cultivating business partnerships with key decision makers, produc...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist
Beacon HillSt. Louis, MissouriFull-time
- Promoted
Senior Accreditation & Regulatory Compliance Specialist
ZipRecruiterSt Louis, MO, United StatesFull-time
- Promoted
- New!
Associate General Counsel III - Regulatory
Edward JonesSaint Louis, MO, United States$168,500.00 yearly
Full-time
SPECIALIST REGULATORY
Vi-JonSt. Louis, MO, US This position is responsible for communicating and tracking customer specific and state agency related Regulatory Compliance information for products manufactured at all facilities including contra...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Compliance Counsel
Kemper CorporationSaint Louis, MO, USFull-time
Consumer Affairs Bank Examiner
Federal Reserve SystemSt. Louis, MO$100,000.00–$150,000.00 yearly
Full-time
Executive Director, Legislative and Regulatory Policy
001_BCBSA Blue Cross and Blue Shield AssociationUS Missouri RemoteRemote
Full-time
Senior Regulatory Affairs Specialist
STERISSt. Louis, MO, US At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Reporting to the Manager, Regu...Show moreLast updated: 30+ days ago
Safety, Regulatory, Quality Site Coordinator
BrenntagSt. Louis, USA Safety, Regulatory, Quality Site Coordinator.Ensure that all required regulatory and safety training is kept up to date.Review accidents, assist locations in investigating serious accidents or near...Show moreLast updated: 30+ days ago
National Tax Services - Tax Controversy Regulatory Services - Director
PwC US Tax LLPSt. Louis,MOFull-time
Senior Regulatory Implementation & Assurance Analyst
Highmark HealthMO, Working at Home, Missouri$124,800.00 yearly
Full-time
Promotions & Events Manager (Pending Regulatory Approval)
PENN EntertainmentSt. Louis, MO, US We’re always looking for talent that believes in having fun.At PENN Entertainment, you’ll get to be a part of an exciting industry, where the days and nights are fast paced.You’ll work with an incr...Show moreLast updated: 30+ days ago
- Promoted
Senior Accreditation & Regulatory Compliance Specialist
MercySt Louis, MO, United StatesFull-time
Medical Director (Medical Affairs)
CVS HealthMissouri, Work At Home, USRemote
Full-time
Regulatory Compliance Specialist
BJC HealthCareSaint Louis, Missouri$63,024.00–$102,627.20 yearly
(Contractor) Regulatory Affairs Specialist
Curium Live ForwardSt. Louis, MO, United States30+ days ago
Job type
- Temporary
Job descriptionAuthoring, organization, and preparation of CTD regulatory filings; also includes peer review of filings Understand, identify potential regulatory risks and recommend strategies based on current ICH and health authority requirements Manage multiple priorities Attend necessary trainings and seminars to keep abreast of new and / or changes in the Regulatory profession. Process, interpret, and provide recommendations for complex, unusual issues. Critically review documentation for regulatory submissions and provide input for necessary revisions. Bachelor Degree in scientific discipline required or equivalent work experience. 3 or more years of Regulatory experience or related field required. Self-starter who takes initiative to learn, grow and excel as a Regulatory Affairs professional. Background in manufacturing, research and development, or quality assurance sufficient to understand how products are produced and marketed. Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally. Cross-functional interaction experience, coordinating activities, driving assigned submissions to completion, and working to align communications with other departments is required. Excellent written and oral communication skills. Use of software system to manage change controls. Strong background using Microsoft Office tools and Adobe Acrobat. Travel Time Required - up to 10% (May vary depending on region / site) Standard office environment Willingness to work in a team-based environment. Close attention to detail required. May be required to sit or stand for long periods of time while performing duties. Must be able to work outside of regular work hours. Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation. Must possess good hand-eye coordination.
Summary of Position
The (Contractor) Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications. Support of regulatory activities including but not limited to :
- Plan / author / compile drug product dossiers in CTD format for expansion to international markets
- Plan / author / compile / submit / manage variations for marketed products outside the United States
- Respond to health authority information requests and comments to achieve approval
- Review and assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
- Participate in cross-functional teams and provide health authority requirements needed for support of initial international filings and post-approval changes
- Facilitate the creation of foreign language labeling content to meet local health authority requirements
- Maintain regulatory knowledge of current guidelines and regulations
- Maintain current regulatory databases and produce various reports as needed
- Provides mentorship for entry-level regulatory associates
Essential Functions
Requirements
Working Conditions :