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Dossier Jobs (NOW HIRING)

Bilfinger

Préparer l'ensemble du dossier de réalisation de projets * Participer au maintien de l'équilibre financier et à la rentabilité de l'Affaire * Gérer les achats de l'affaire en cours (appel ...

Waste Pro

Regional Fleet Specialist

Midway, FL · On-site

Provides Dossier training within the region, ensuring accurate and timely entries by field personnel. * Leads Warranty Recovery procedures to maximize warranty application when available.

Taiho Oncology

$86K - $102K/yr

Contributes to the development and implementation of dossier publishing processes and procedures to improve efficiency and meet health authority standards. Interacts with regulatory affairs and ...

Ag

Process Engineer

Kinston, NC · On-site

Create and maintain an Integrated Manufacturing Dossier from the Definition Dossier, including Standard Operating Instructions. Produce detailed optimized processes with appropriate STV calculations.

Ecole de technologie superieure

Le dossier de candidature devra inclure les documents suivants : * une lettre de presentation; * un curriculum vitae; * un enonce des objectifs en enseignement; Pour toute autre information, les ...

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How much do dossier jobs pay per week?

As of Aug 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 is a dossier?

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 skills and qualifications are needed to thrive as a dossier manager?

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 common challenges faced by professionals 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 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.

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What states have the most Dossier jobs?

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Dossier jobs near you
Infographic showing various Dossier job openings in the United States as of August 2026, with employment types broken down into 92% Full Time, 7% Part Time, and 1% Contract. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $52,896 per year, or $25.4 per hour.

Director, Regulatory Affairs (Global Filing Lead)

Revolution Medicines

Redwood City, CA • Hybrid

$183K - $242K/yr

Full-time

Re-posted 13 days ago

Job description

The Opportunity:

The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA & global filing regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration

  • High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the EU, UK, Japan and internationally.

  • Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

  • Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

  • Coordinate dossier filing and sub-team rosters for management endorsement.

  • Lead cross-functional MAA kickoff according to global filing plans and framework.

  • Maintain & track an integrated filing plan including regulatory timelines, modular MAA deliverables, critical path activities, in concert with Regulatory Program Management.

  • Identify, respond to, and proactively mitigate risks to filing timelines or regulatory outcomes and report progress to senior management.

  • Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

  • Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

  • Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

  • Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

  • Proven success in executing global NDA/MAAs (preparation, submission & approval).

  • Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

  • Demonstrated ability to lead Health Authority interactions and negotiations.

  • In-depth knowledge of CTD structure and management of dossier components.

  • Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

  • Flexibility to support business needs of dynamic registrational programs.

  • Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

  • Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

  • Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.

  • An advanced degree is desirable. 

    #LI-Hybrid  #LI-SH1

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