Manager, Regulatory Operations and Publishing

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee daily operations related to regulatory submissions.

• Prepare intricate documents in accordance with company standards to enhance PDF rendering.

• Create submission-ready PDFs that adhere to regulatory guidelines, eCTD requirements, and internal protocols.

• Conduct technical quality control of submission documents and published submissions.

• Manage tracking of deliverables, coordinate timelines, assess submission readiness, and facilitate communication with stakeholders.

• Collaborate with external submission vendors.

• Offer technical assistance to authoring teams utilizing StartingPoint templates.

• Assist with reference management using EndNote or similar tools.

• Work alongside Regulatory Affairs and cross-functional teams to address formatting, publishing, and quality control challenges.

• Aid in the creation and upkeep of records and documents within Veeva Vault RIM and other systems.

• Contribute to the development and enhancement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.

• Stay updated on FDA, ICH, and other relevant electronic submission and document standards.

⛳️ Requirements

• Bachelor's degree with a minimum of 4 years of experience in Regulatory Operations.

• Familiarity with Accenture StartingPoint Templates and Veeva RIM is preferred.

• Proficient in Microsoft Word formatting, PDF publishing, and preparation of submission documents.

• Solid understanding of eCTD submission structure, PDF specifications, bookmarks, hyperlinks, file naming conventions, and standards for submission-ready documents.

• Experience in conducting technical quality control for regulatory submissions and published eCTD sequences.

• Extremely detail-oriented with a strong emphasis on accuracy, consistency, and quality.

• Exceptional organizational skills and the ability to handle multiple simultaneous submissions and competing priorities.

• Capable of troubleshooting complex document formatting and PDF publishing issues.

• Ability to work autonomously and see tasks through from initiation to completion.

• Strong communication and interpersonal abilities.

• Effective collaboration with internal teams and external vendors.

• Proactive, professional demeanor with self-confidence.

• High ethical standards and integrity in professional conduct.

• Capacity to sit, reach with hands and arms, and communicate regularly.

• Ability to occasionally lift and/or move items weighing up to 15 pounds.

• Proficiency in both close and distance vision.

🏝️ Benefits

• Additional incentive cash and stock opportunities (subject to eligibility).

• Comprehensive medical, pharmacy, dental, and vision coverage.

• BMS Well-Being Account.

• BMS Living Life Better program.

• Employee Assistance Programs (EAP).

• 401(k) retirement plan.

• Short- and long-term disability coverage.

• Life insurance protection.

• Accident insurance options.

• Supplemental health insurance plans.

• Business travel insurance.

• Personal liability coverage.

• Identity theft protection benefits.

• Legal support services.

• Survivor support resources.

• Flexible time off policy (unlimited, with manager approval) for eligible US exempt employees.

• 11 paid national holidays for eligible US exempt employees.

• 160 hours of annual paid vacation for eligible employees in Phoenix, AZ, Puerto Rico, and RayzeBio.

• 3 optional holidays for eligible employees in Phoenix, AZ, Puerto Rico, and RayzeBio.

• Unlimited paid sick leave, based on eligibility.

• Up to 2 paid volunteer days per year, depending on eligibility.

• Flexible summer hours, contingent on eligibility.

• Leaves of absence available for medical, personal, parental, caregiver, bereavement, and military purposes.

• Annual Global Shutdown observed between Christmas and New Year’s Day.