Job Title: Manager, Regulatory Operations and Publishing
Department: Regulatory
Location: Remote
FLSA Status: Exempt
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.
- Manage day-to-day regulatory submission operations activities to ensure high-quality, timely, and compliant health authority submissions.
- Format complex documents according to company formatting standards to optimize PDF rendering and limit manual publishing of PDF documents.
- Generate submission-ready PDFs in compliance with regulatory guidance, eCTD requirements, and internal PDF publishing standards.
- Perform technical QC of submission documents and published submissions to ensure accuracy, consistency, completeness, and compliance with submission requirements.
- 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.
- Coordinate with external submission vendors to support timely and high-quality submission delivery.
- Provide technical support to authoring teams on the use of StartingPoint templates.
- Support reference management activities, including maintaining references in EndNote or other reference management tools.
- Partner with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting, publishing, and QC issues.
- Support creation and maintenance of data, records, and documents in Veeva Vault RIM and other systems, as applicable.
- Support development and continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
- Maintain current knowledge of FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document standards.
Education and Experience- Bachelor's degree with 4+ years of Regulatory Operations experience
- Experience with Accenture StartingPoint Templates and Veeva RIM preferred
Skills and Qualifications- 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.
Physical DemandsWhile 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.
#LI-REMOTE
Compensation Overview:Remote - United States - US: $134,505 - $162,988
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers SquibbRayzeBio 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.
