Top 33 Senior researcher Jobs in St. Louis, Mo

Senior Regulatory Affairs Specialist
Curium Pharma —St. Louis, MO
- Overtime
- 5 years
- Mid-level
- Office
Administrative Assistant - Editor
Harris-Stowe State University —St. Louis, MO
- Full-time
- English
- Mid-level
- Office
Quick Apply
Senior Director Marketing
Curium Pharma —St. Louis, MO
- Marketing
- 5 years
- Office
Research Scientist or Senior Research Associate - Taylor Lab
DONALD DANFORTH PLANT SCIENCE CENTER —St. Louis, MO
- Full-time
- 5 years
- Analysis skills
- Doctor of Philosophy
Planner II (Interiors) - Enterprise Physical Operations
Washington University in St. Louis —St. Louis, MO
- $84,200 - $148,500 a year
- Online Application
- Civil engineering
- Writing skills
- Pass drug screening
- Commuter assistance
- Employee assistance program
Senior Scientist - Bursky Public Health
Washington University in St. Louis —St. Louis, MO
- $63,400 - $115,000 a year
- Online Application
- Pass drug screening
- Office
- University
- Commuter assistance
- Employee assistance program
Sr. Health Project Planner I
CannonDesign —St. Louis, MO
- Contract
- 11+ years
- Mentoring
- Senior level
Medical Outcomes Liaison, Central
UCB —St. Louis, MO
- $156,000 - $238,400 a year
- Weekends as needed
- Medicine
- Office
- 3 years
Response Officer II (Overnight) - Enterprise Physical Operations
Washington University in St. Louis —St. Louis, MO
- $23.37 - $36.19 an hour
- Online Application
- Clean driving record
- Experience working with individuals with disabilities
- Computer literacy
- Commuter assistance
- Employee assistance program
Senior Manufacturing Technician
Curium Pharma —Maryland Heights, MO
- Overtime
- Mid-level
- 3 years
- High school diploma or GED
Senior Medical Science Liaison (KS, MO, OK, AR)
Summit Therapeutics —St. Louis, MO
- $200,000 - $235,000 a year
- Medicine
- Doctor of Philosophy
- Travel
Quick Apply
Research Assistant - Pathology & Immunology
Washington University in St. Louis —St. Louis, MO
- $17.10 - $29.09 an hour
- Online Application
- Writing skills
- Pass drug screening
- Maintenance
- Commuter assistance
- Employee assistance program
Senior Project Manager
Curium Pharma —St. Louis, MO
- Weekends as needed
- Microsoft Word
- Microsoft Excel
- 5 years
Director, Physical Security Systems and Access Control - Enterprise Physical Operations
Washington University in St. Louis —St. Louis, MO
- $110,300 - $194,200 a year
- Online Application
- Clean driving record
- Pass drug screening
- Office
- Commuter assistance
- Employee assistance program
14d
Data Scientist
Harris-Stowe State University —St. Louis, MO
- Full-time
- Computer science
- Anatomy knowledge
- Computer Science
Quick Apply
Team Lead, Senior Project Manager - Enterprise Physical Operations
Washington University in St. Louis —St. Louis, MO
- $96,000 - $169,300 a year
- Online Application
- Writing skills
- Engineering
- Pass drug screening
- Commuter assistance
- Employee assistance program
4d
VP Supply Chain
Curium Pharma —St. Louis, MO
- Weekends as needed
- 11+ years
- Travel
- Mentoring
Response Officer I (Overnight) - Enterprise Physical Operations
Washington University in St. Louis —St. Louis, MO
- $19.29 - $29.91 an hour
- Online Application
- Clean driving record
- Computer literacy
- Writing skills
- Commuter assistance
- Employee assistance program
Senior Process Engineer
Curium Pharma —Maryland Heights, MO
- Weekends as needed
- 5 years
- Engineering
- Travel
Senior Technical Project Manager (Hybrid) - Radiology
Washington University in St. Louis —St. Louis, MO
- $96,000 - $169,300 a year
- Online Application
- Hybrid work
- Computer science
- 7 years
- Computer Science
- Commuter assistance
- Employee assistance program

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Senior Regulatory Affairs Specialist

Curium Pharma -
St. Louis, MO

Apply Now

Job Details

Qualifications

Project team coordination
Document viewing software
Cross-functional team management
Adobe Acrobat
Cross-functional communication

Full Job Description

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Regulatory Affairs Specialist's responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to:

Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of post-approval changes
Author/compile/submit post-approval change supplements
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Provides mentorship for entry-level and intermediate-level regulatory associates

Essential Functions

Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings.
Understand, identify potential regulatory risks and recommend strategies based on current FDA/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.
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

Bachelor Degree in scientific discipline required or equivalent work experience.
5 or more years of Regulatory experience or related field. RAC certification preferred.
Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.
Project leadership or supervisory experience is preferred.
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
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 8+ hours a day while performing duties.
The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Apply Now

Refine Your Search

senior researcher jobs in st. louis, mo

Senior Regulatory Affairs Specialist

Administrative Assistant - Editor

Senior Director Marketing

Research Scientist or Senior Research Associate - Taylor Lab

Planner II (Interiors) - Enterprise Physical Operations

Senior Scientist - Bursky Public Health

Sr. Health Project Planner I

Medical Outcomes Liaison, Central

Response Officer II (Overnight) - Enterprise Physical Operations

Senior Manufacturing Technician

Senior Medical Science Liaison (KS, MO, OK, AR)

Research Assistant - Pathology & Immunology

Senior Project Manager

Director, Physical Security Systems and Access Control - Enterprise Physical Operations

Data Scientist

Team Lead, Senior Project Manager - Enterprise Physical Operations

VP Supply Chain

Response Officer I (Overnight) - Enterprise Physical Operations

Senior Process Engineer

Senior Technical Project Manager (Hybrid) - Radiology

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