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Dossier Jobs (NOW HIRING)

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 ...

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 ...

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Dossier information

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$567

$1K

$1.7K

How much do dossier jobs pay per week?

As of May 30, 2026, the average weekly pay for dossier in the United States is $1,017.23, according to ZipRecruiter salary data. Most workers in this role earn between $807.69 and $1,173.08 per week, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Dossier Manager, and why are they important?

To excel as a Dossier Manager, you need expertise in document management, regulatory compliance, and strong organizational skills, often backed by a degree in life sciences or a related field. Familiarity with electronic document management systems (EDMS), regulatory submission platforms, and industry-specific standards like eCTD is crucial. Attention to detail, effective communication, and project management abilities are key soft skills that enhance performance in this role. These skills ensure accurate, timely, and compliant dossier submissions, which are critical for regulatory approval and company success.

What are some common challenges faced by professionals responsible for managing dossiers, and how can they be addressed?

Professionals managing dossiers often encounter challenges such as maintaining accurate and up-to-date documentation, ensuring compliance with regulatory standards, and coordinating information from multiple stakeholders. Staying organized and implementing robust document management systems can help mitigate these issues. Additionally, clear communication with cross-functional teams and ongoing training on regulatory changes are essential for staying compliant and efficient in this role.

What is a dossier in a professional context?

A dossier is a collection of documents, records, or information compiled about a specific person, subject, or project. In professional settings, dossiers are used to organize and present comprehensive information for decision-making, evaluations, or reporting. They can include resumes, reports, references, and other relevant materials, depending on their purpose. Dossiers are commonly used in fields like law, healthcare, business, and government to ensure all pertinent information is easily accessible and well-organized.

What is the difference between Dossier vs Case Manager?

AspectDossierCase Manager
Required CredentialsTypically requires a high school diploma or equivalent; some roles may need certifications in record managementRequires a bachelor's degree in social work, healthcare, or related fields; certifications may be preferred
Work EnvironmentOffice settings, record storage facilities, administrative environmentsHealthcare facilities, social service agencies, client-facing settings
Employer & Industry UsageUsed mainly in legal, administrative, and record-keeping contextsCommon 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.

More about Dossier jobs
What cities are hiring for Dossier jobs? Cities with the most Dossier job openings:
What states have the most Dossier jobs? States with the most job openings for Dossier jobs include:
Manager Regulatory Affairs-CMC

Other

Medical, Life

Posted 26 days ago


Job description

Company 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 Description

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.


Additional Information

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 MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724
LinkedIn: 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)


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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