Summary

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.

Job description

Job Responsibilities

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.

Requirements

Bachelor's degree
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

Benefits

Medical, Dental & Vision
Life & Disability Insurance
Retirement Benefits
Financial Protection Benefits
Flexible Time Off
11 Paid Company Holidays
Paid Sick Leave
Volunteer Days
Summer Hours Flexibility
Parental Leave
Bereavement Leave
Global Shutdown

Company overview

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.