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New · posted Oct 21

Bristol Myers Squibb · Pharmaceuticals

Manager, Regulatory Operations and Publishing

  • Remote, US
  • Remote
  • Full-time
  • Manager
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Pay$119K–$144Ka year · employer provided
EmploymentFull-time
LocationRemote, USRemote
LevelManager
FunctionRegulatory OperationsRegulatory
Deadline

Closes Oct 27, 2026 · 5 days left

What you need

  • Bachelor’s degree with 4+ years of Regulatory Operations experience
  • Experience with Accenture StartingPoint Templates and Veeva RIM preferred
  • Demonstrated expertise in Microsoft Word formatting, PDF publishing, and submission document preparation.
  • Strong understanding of eCTD submission structure, PDF specifications, bookmarks, hyperlinks, file naming, and submission-ready document standards.
  • Experience performing technical quality control of regulatory submissions and published eCTD sequences.
  • Highly detail-oriented, with strong focus on accuracy, consistency, and quality.
  • Strong organizational skills, with the ability to manage multiple concurrent submissions and competing priorities.
  • Ability to troubleshoot complex document formatting and PDF publishing issues.
  • Ability to work independently and follow tasks through from start to finish.
  • Strong communication and interpersonal skills.
  • Ability to collaborate effectively with internal teams and external vendors.
  • Proactive, professional, and confident.
  • Excellent professional ethics and integrity.

Skills named in this posting

What you'll do

Essential duties and responsibilities include the following. Other duties may be assigned.

  1. Manage day-to-day regulatory submission operations activities to ensure high-quality, timely, and compliant health authority submissions.
  2. Format complex documents according to company formatting standards to optimize PDF rendering and limit manual publishing of PDF documents.
  3. Generate submission-ready PDFs in compliance with regulatory guidance, eCTD requirements, and internal PDF publishing standards.
  4. Perform technical QC of submission documents and published submissions to ensure accuracy, consistency, completeness, and compliance with submission requirements.
  5. Manage submission execution activities, including deliverable tracking, timeline coordination, submission readiness assessments, and communication with Regulatory Affairs and cross-functional stakeholders to ensure timely submission delivery.
  6. Coordinate with external submission vendors to support timely and high-quality submission delivery.
  7. Provide technical support to authoring teams on the use of StartingPoint templates.
  8. Support reference management activities, including maintaining references in EndNote or other reference management tools.
  9. Partner with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting, publishing, and QC issues.
  10. Support creation and maintenance of data, records, and documents in Veeva Vault RIM and other systems, as applicable.
  11. Support development and continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
  1. Maintain current knowledge of FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document standards.

Pay

$119,116 – $144,341 a year

Employer provided
How this compares

Compensation Overview

Remote - United States - US: $119,116 - $144,341

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

Working conditions

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Department: Regulatory

Location: Remote

A team of smiling Bristol Myers Squibb colleagues cheering as a coworker stacks cups in an office game

From the posting

About Bristol Myers Squibb

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

FLSA Status: Exempt

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Bristol Myers Squibb company page · 50 open roles
Equal opportunity, accessibility and legal noticesBristol Myers Squibb's statements, word for word

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605078 : Manager, Regulatory Operations and Publishing

Job intelligence

The context around this role

Live data · October 23, 2026

Salary intelligence

How the pay compares

This role's midpoint is 25% below the US median for Regulatory Operations roles at this level.

This roleEmployer provided

$119,116 to $144,341 a year

Manager roles in the US12 roles publishing pay

Middle half $145,875 to $183,750, median $176,000
Annual base pay
Annual base payLowMedianHigh
This role$119,116—$144,341
All US$145,875$176,000$183,750

This role: Bristol Myers Squibb's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Operations

The general path across 42 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Bristol Myers Squibb's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Regulatory Operations Specialist · Associate Specialist, Regulatory Affairs Operations TMTT

    $80K median9 open

  2. One step back

    Senior & Principal

    Often: Senior Associate, Regulatory Affairs Submission Management · Senior Associate, Regulatory Affairs

    $124K median6 open

  3. This role

    Manager

    Often: Manager, Regulatory Operations · Senior Manager, Regulatory Operations

    $176K median13 open

  4. Next step

    Director

    Often: Associate Director, Regulatory Business Systems & Capability Strategy · Associate Director, Regulatory Operations

    $199K median13 open

  5. Later

    VP & Executive

    Often: Vice President, Head of Global Regulatory Operations

    1 open

Career resources on Regulatory Operations

Skills DNA

What this role leans on

How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 2 linesDocumentation and SOPs: 9 linesRegulatory submissions: 11 linesQuality systems and risk: 1 lineData and digital systems: 2 linesCollaboration and leadership: 4 linesGMPDocumentationSubmissionsQuality systemsData systemsTeamwork
  • Regulatory submissions11
  • Documentation and SOPs9
  • Collaboration and leadership4
  • GMP and compliance2
  • Data and digital systems2
  • Quality systems and risk1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Bristol Myers Squibb on Regulatory Jobs

50
Open roles
48
Distinct roles
10
Locations

By discipline

  • Quality42 84%
  • Regulatory8 16%

By level

  • Senior & Principal19 38%
  • Associate & Specialist12 24%
  • Manager10 20%
See all 50 Bristol Myers Squibb roles

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Manager, Regulatory Operations and Publishing at Bristol Myers Squibb

Applications close October 27. $119K–$144K a year, employer provided.

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