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Regulatory specialist Jobs in St Louis, MO

Last updated: 1 day ago
(Contractor) Regulatory Affairs Specialist

(Contractor) Regulatory Affairs Specialist

Curium Live ForwardSt. Louis, MO, United States
Temporary
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
Managing Consultant, Environmental Regulatory Specialist (Senior Level)

Managing Consultant, Environmental Regulatory Specialist (Senior Level)

ERMSt Louis, Missouri
$76,000.00–$94,860.00 yearly
Full-time
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
  • Promoted
Recovery Specialist

Recovery Specialist

Chestnut Health SystemsBrooklyn, Illinois, United States
$19.00–$20.00 hourly
Full-time
OverviewShare your recovery experience to help others in your role as a Recovery Specialist at Chestnut.Experience the satisfaction of helping to facilitate self-directed recovery.It is based in Gr...Show moreLast updated: 1 day ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Beacon HillSt. Louis, Missouri
Full-time
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
  • Promoted
Senior Accreditation & Regulatory Compliance Specialist

Senior Accreditation & Regulatory Compliance Specialist

ZipRecruiterSt Louis, MO, United States
Full-time
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: 5 days ago
  • Promoted
Associate General Counsel III - Regulatory

Associate General Counsel III - Regulatory

Edward JonesSaint Louis, MO, United States
$168,500.00 yearly
Full-time
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: 2 days ago
SPECIALIST REGULATORY

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

Regulatory Compliance Counsel

Kemper CorporationSaint Louis, MO, US
Full-time
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: 2 days ago
Executive Director, Legislative and Regulatory Policy

Executive Director, Legislative and Regulatory Policy

001_BCBSA Blue Cross and Blue Shield AssociationUS Missouri Remote
Remote
Full-time
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
Senior Regulatory Affairs Specialist

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

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
  • Promoted
COMPLAINTS QUALITY MANAGEMENT TEAM LEAD, RISK AND REGULATORY

COMPLAINTS QUALITY MANAGEMENT TEAM LEAD, RISK AND REGULATORY

Block, IncMO, United States
$69,300.00–$103,900.00 yearly
Full-time
It all started with an idea at Block in 2013.Initially built to take the pain out of peer-to-peer payments, Cash App has gone from a simple product with a single purpose to a dynamic ecosystem, dev...Show moreLast updated: 2 days ago
Insourced Solutions for Tax - Controversy & Regulatory Director

Insourced Solutions for Tax - Controversy & Regulatory Director

PwC US Tax LLPSt. Louis,MO
Full-time
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
Promotions & Events Manager (Pending Regulatory Approval)

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
Regulatory Compliance Specialist

Regulatory Compliance Specialist

BJC HealthCareSaint Louis, Missouri
$63,024.00–$102,627.20 yearly
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
Senior Regulatory Implementation & Assurance Analyst

Senior Regulatory Implementation & Assurance Analyst

Highmark HealthMO, Working at Home, Montana
$124,800.00 yearly
Full-time
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
  • Promoted
Senior Accreditation & Regulatory Compliance Specialist

Senior Accreditation & Regulatory Compliance Specialist

MercySaint Louis, MO, United States
Full-time
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: 2 days ago
Supply Chain Planning & Regulatory IT Solution Owner

Supply Chain Planning & Regulatory IT Solution Owner

Merck KGaA, Darmstadt, GermanySt. Louis, United States
We are looking for business and IT talent to lead the design, build and deployment of a new LS ERP process & system template. This role will be positioned with a strong link to senior business and I...Show moreLast updated: 30+ days ago
(Contractor) Regulatory Affairs Specialist

(Contractor) Regulatory Affairs Specialist

Curium Live ForwardSt. Louis, MO, United States
30+ days ago
Job type
  • Temporary
Job description

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

  • Authoring, 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.
  • Requirements

  • 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)
  • Working Conditions :

  • 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.