Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives. Responsibilities: 50% of the time develops global CMC ...
Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives. Responsibilities: 50% of the time develops global CMC ...
Quality Responsible Engineer
Houston, TX · On-site
$68.80K - $88.80K/yr
... Dossier) to meet client specifications, applicable codes/standards, and project quality objectives. This position is a key integrator between engineering requirements, vendor manufacturing ...
Quality Responsible Engineer
Houston, TX · On-site
$68.80K - $88.80K/yr
... Dossier) to meet client specifications, applicable codes/standards, and project quality objectives. This position is a key integrator between engineering requirements, vendor manufacturing ...
Senior Healthcare Enterprise Account Executive Remote
Manhattan, NY · Remote
$100K/yr
A healthcare-focused SaaS company is seeking an experienced Enterprise Account Executive to drive new business with large health systems across the U.S. This fully remote position requires owning the ...
Senior Healthcare Enterprise Account Executive Remote
Manhattan, NY · Remote
$100K/yr
A healthcare-focused SaaS company is seeking an experienced Enterprise Account Executive to drive new business with large health systems across the U.S. This fully remote position requires owning the ...
Quality Responsible Engineer
Houston, TX · On-site
$68.80K - $88.80K/yr
... Dossier) to meet client specifications, applicable codes/standards, and project quality objectives. This position is a key integrator between engineering requirements, vendor manufacturing ...
Quality Responsible Engineer
Houston, TX · On-site
$68.80K - $88.80K/yr
... Dossier) to meet client specifications, applicable codes/standards, and project quality objectives. This position is a key integrator between engineering requirements, vendor manufacturing ...
Applicants to this position receive a free Dossier account and can send all application materials, including confidential letters of recommendation, free of charge. Please review Interfolio dossier ...
Applicants to this position receive a free Dossier account and can send all application materials, including confidential letters of recommendation, free of charge. Please review Interfolio dossier ...
Applicants to this position receive a free Dossier account and can send all application materials, including confidential letters of recommendation, free of charge. Please review Interfolio dossier ...
Applicants to this position receive a free Dossier account and can send all application materials, including confidential letters of recommendation, free of charge. Please review Interfolio dossier ...
The job purpose is to prepare technical CMC registration documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency ...
The job purpose is to prepare technical CMC registration documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency ...
Operates as the functional area expert in terms of dossier production, provides direction, fosters effective team skills, and drives production of results based upon experience. 13. Establishes and ...
Operates as the functional area expert in terms of dossier production, provides direction, fosters effective team skills, and drives production of results based upon experience. 13. Establishes and ...
Manage our Dossier Truck Software Skills and Qualifications: * Proven experience in parts management, preferably in the automotive or diesel industry. * Strong organizational and multitasking skills.
Manage our Dossier Truck Software Skills and Qualifications: * Proven experience in parts management, preferably in the automotive or diesel industry. * Strong organizational and multitasking skills.
Parts and Inventory Specialist - Diesel Shop
Townsend, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Townsend, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Milledgeville, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Milledgeville, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Director, Regulatory Affairs (Global Filing Lead)
Redwood City, CA · Hybrid
$183.70K - $242.40K/yr
They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational ...
Director, Regulatory Affairs (Global Filing Lead)
Redwood City, CA · Hybrid
$183.70K - $242.40K/yr
They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational ...
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
Quick apply
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
Director, Regulatory Affairs - Global Filing Lead
Redwood City, CA · Hybrid
$183.70K - $242.40K/yr
They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational ...
Director, Regulatory Affairs - Global Filing Lead
Redwood City, CA · Hybrid
$183.70K - $242.40K/yr
They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational ...
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
Parts and Inventory Specialist - Diesel Shop
Milledgeville, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Milledgeville, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document ...
Parts and Inventory Specialist - Diesel Shop
Townsend, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Townsend, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Manage our Dossier Truck Software Skills and Qualifications: * Proven experience in parts management, preferably in the automotive or diesel industry. * Strong organizational and multitasking skills.
Manage our Dossier Truck Software Skills and Qualifications: * Proven experience in parts management, preferably in the automotive or diesel industry. * Strong organizational and multitasking skills.
Parts and Inventory Specialist - Diesel Shop
Fairburn, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Parts and Inventory Specialist - Diesel Shop
Fairburn, GA · On-site
$22 - $25/hr
... Dossier Truck Software Skills and Qualifications: - Proven experience in parts management, preferably in the automotive or diesel industry. - Strong organizational and multitasking skills ...
Dossier information
See salary details
$567.31 - $673.08
14% of jobs
$673.08 - $778.85
4% of jobs
$831.73 is the 25th percentile. Wages below this are outliers.
$778.85 - $884.62
14% of jobs
The median wage is $974.52 / hr.
$884.62 - $990.38
21% of jobs
$990.38 - $1.1K
15% of jobs
$1.1K is the 75th percentile. Wages above this are outliers.
$1.1K - $1.2K
14% of jobs
$1.2K - $1.3K
12% of jobs
$1.3K - $1.4K
6% of jobs
$1.4K - $1.5K
0% of jobs
$1.5K - $1.6K
0% of jobs
$1.6K - $1.7K
0% of jobs
$567
$1K
$1.7K
How much do dossier jobs pay per week?
What are the key skills and qualifications needed to thrive as a Dossier Manager, and why are they important?
What are some common challenges faced by professionals responsible for managing dossiers, and how can they be addressed?
What is a dossier in a professional context?
What is the difference between Dossier vs Case Manager?
| Aspect | Dossier | Case Manager |
|---|---|---|
| Required Credentials | Typically requires a high school diploma or equivalent; some roles may need certifications in record management | Requires a bachelor's degree in social work, healthcare, or related fields; certifications may be preferred |
| Work Environment | Office settings, record storage facilities, administrative environments | Healthcare facilities, social service agencies, client-facing settings |
| Employer & Industry Usage | Used mainly in legal, administrative, and record-keeping contexts | Common in healthcare, social services, and community support industries |
While both roles involve managing information, a Dossier focuses on organizing and maintaining records, whereas a Case Manager actively coordinates services and supports clients' needs. Understanding these differences helps in choosing the right career path or job search focus.
Other
Medical, Life
Posted 26 days ago
Job description
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Title: Manager Regulatory Affairs-CMC
Location: Lexington, MA
Duration: 4+months (Possibility of extension)
Business Function: R&D
Department Name: Global Regulatory Affairs
Primary Role:
Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions.
Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives.
Responsibilities:
50% of the time develops global CMC Core Dossier for Module 2.3 and Module 3 CTD sections
50% of the time prepares CMC components of new Marketing Authorization Applications for international countries
EDUCATION & EXPERIENCE
Requirements:
Bachelor's degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.
Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics/small molecule drug development and registration activities.
Key Skills and Competencies:
Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement
Ensures timely delivery of high quality regulatory submissions
Must be highly organized, committed to excellence, and possess both determination and attention to detail.
We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBEÂ |GSA - Schedule 66Â IÂ GSA - Schedule 621I
DIRECT # -Â 732-844-8724
LinkedIn:Â https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified  for Health Care Staffing
"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996