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Dossier Jobs (NOW HIRING)

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 ...

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.

Neurelis Inc

Director, Medical Information

San Diego, CA · On-site

$213K - $237K/yr

The Director will apply scientific expertise to address escalated product and disease-state inquiries, develop quarterly internal newsletters, maintain AMCP dossier updates, and provide scientific ...

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.

Airbus

Process Engineer

Kinston, NC · On-site

Primary Responsibilities: 1. Process Optimization: (45%) • Ensure the industrial feasibility of the Definition Dossier. • Create and maintain an Integrated Manufacturing Dossier from the ...

Airbus

Process Engineer

Kinston, NC · On-site

Primary Responsibilities: 1. Process Optimization: (45%) • Ensure the industrial feasibility of the Definition Dossier. • Create and maintain an Integrated Manufacturing Dossier from the ...

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How much do dossier jobs pay per week?

As of Aug 8, 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 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.

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 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.
More about Dossier jobs
What cities are hiring for Dossier jobs? Cities with the most Dossier job openings:
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What job categories do people searching Dossier jobs look for? The top searched job categories for Dossier jobs are:
Dossier jobs near you
Infographic showing various Dossier job openings in the United States as of August 2026, with employment types broken down into 87% Full Time, 7% Part Time, 5% Temporary, and 1% Contract. Highlights an 96% Physical, 2% Hybrid, and 2% Remote job distribution, with an average salary of $52,896 per year, or $25.4 per hour.

Senior Regulatory Affairs Specialist

International Executive Service Corps

San Francisco, CA • On-site

$150 - $185/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 3 days ago

New

Job description

Nektar has an exciting opportunity for a Sr. Regulatory Affairs Specialist on the Regulatory Affairs Team.

Position Summary

This role supports end-to-end planning and delivery of global clinical submissions, assists with the creation and release of core regulatory dossier sections, and aids in the high-quality work to support ongoing clinical programs. The Senior Specialist, Clinical Regulatory Affairs will be a part of clinical program teams and will be working closely with a variety of functions which include Clinical Operations, Clinical Development, Safety, and CMC leadership.

Support Strategic Regulatory Leadership
  • Supports the Regulatory Affairs Department across multiple company-sponsored projects and, under supervision, leads the assembly of regulatory dossiers for review by senior Regulatory Affairs management. Contributes to the company’s research and development efforts to develop high-value therapeutics.
  • Support the company’s planned global clinical regulatory strategy by representing Clinical Regulatory at the functional team level and assist with clinical development milestones.
  • Support senior regulatory advisor(s) in clinical program teams and contribute to regulatory strategy discussions.
  • Stay abreast of the regulatory landscape and regulatory requirements. Communication regulatory challenges and possible mitigation strategies.
  • Represent Regulatory Affairs in functional team forums, providing decision-making support and regulatory insights to senior management.
  • Support the planning, authorship, review, and delivery of all major clinical regulatory submissions, including:
    • New Drug Application (NDA)
    • IND/CTA filings and amendments
    • Health authority pre-submission and post-submission packages
    • DSURs, Annual Reports, SUSAR submissions
    • Protocols, IBs, and related clinical documentation
  • Support or lead cross-functional submission teams with CROs, ensuring clarity of roles, timelines, and quality expectations.
  • Support the established and continuously optimize submission processes, tools, templates, and governance standards.
Core Dossier Management & Country Customization
  • Support the development, release, and lifecycle management of global core clinical dossiers, ensuring scientific rigor, regulatory compliance, and internal alignment.
  • Understand and aid the strategies for efficient global rollout, including harmonization across regions and scalable dossier architecture.
  • Contribute to executive-level guidance to regional teams on country-specific customization, ensuring adherence to local regulations, formats, language requirements, and health authority expectations.
  • Coordinate approvals of localized submissions for strategic consistency and regulatory integrity.
  • Collaborate with Regulatory Operations on archiving submission dossiers.
Clinical Operations Partnership & Trial Execution
  • Partner with members of the functional clinical program teams to ensure regulatory considerations are fully integrated into trial startup, conduct, and closeout.
  • Support regional feasibility and startup planning from a regulatory perspective, including country prioritization and risk management.
  • Assist with oversight of vendor and CRO performance related to regulatory responsibilities.
  • Support organization-wide inspection readiness and aid senior team members with oversight during audits and regulatory inspections.
Qualifications Required
  • Bachelor’s degree in life sciences or related field.
  • 8 years of experience in biotech/pharma, with a minimum of 4 years hands‑on Regulatory Affairs experience handling drugs or medical devices.
  • Demonstrated knowledge of global IND/CTA submission types, dossier management, and regulatory interactions.
  • Basic knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.).
  • Experience with communication to cross-functional leaders and supporting alignment on regulatory strategy.
  • Strong and dynamic communication and organizational skills.
  • Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset. Ability to use Internet for research applications is required.
Preferred
  • Experience with biologics, gene therapies, cell therapies, or other advanced modalities.
  • Prior experience with global clinical trials and rollout of core clinical dossiers or large‑scale clinical submission programs.
  • Advanced degree, RAC certification, or equivalent credential.
  • Experience in fast‑paced or emerging biotech environments.
Additional Information

Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $150,000 to $185,000 for candidates in the Bay Area and will depend, in part, on successful candidate’s location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

  • Health Insurance (Medical/Dental/Vision)
  • Disability Insurance
  • Holiday Pay
  • Paid Time Off (PTO)
  • 401(k) Match
  • Employee Stock Purchase Plan
  • Wellness Programs
  • Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.nektar.com/careers.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

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