Senior Manager, Regulatory Program Support

Shionogi Inc. (U.S.)

. Provide end-to-end operational delivery of assigned regulatory submissions .

Posted 10/16/2026full-timeFlorham Park • New Jersey • United StatesSenior💰 $140,000 - $170,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submission management, including planning, coordinating, and executing complex regulatory documents and timelines. Proficient in cross-functional collaboration and mentoring, with a strong understanding of U.S. regulatory requirements and lifecycle management.

Highest-signal resume keywords

Regulatory Submission ManagementIND/NDA Lifecycle MaintenanceCross-Functional CoordinationRegulatory Document Quality ControlProject Planning Tools Proficiency

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Submission ManagementIND/NDA Lifecycle MaintenanceRegulatory Document Quality ControlComplex Timeline ManagementRegulatory Archiving ActivitiesSubmission Readiness ReviewRisk Mitigation PlanningDocument DraftingRegulatory Action TrackingTrial Master File Activities

Soft Skills

Strong Planning SkillsEffective CommunicationOperational JudgmentMentoring AbilityAttention to Detail

Tools & Technologies

Document Management SystemsProject Planning ToolsStandard Office Applications

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryRegulatory AffairsGlobal Regulatory SubmissionsRegulatory ProcessesClinical Study TeamsOperational Execution

About the role

Key responsibilities & impact

Provide end-to-end operational delivery of assigned regulatory submissions
Plan, coordinate, prepare, review, and submit regulatory documents
Serve as operational point of contact for designated applications and support IND/NDA lifecycle maintenance
Develop and adjust submission and execution plans, sequence activities, and resolve cross-functional dependencies
Review documents for completeness, consistency, readability, formatting, cross-references, hyperlinks, submission readiness, and technical requirements
Contribute to major regulatory submissions through drafting document sections and quality-control reviews
Perform regulatory archiving activities
Maintain regulatory timelines, trackers, submission plans, risk logs, and investigator trackers
Track regulatory action items, commitments, information requests, and post-submission activities
Lead cross-functional coordination, including meetings, documentation, action items, and follow-up
Create and maintain complex master timelines for INDs, NDAs, and MAAs
Draft, maintain, annotate, and quality-control labeling components through development, submission, approval, and implementation
Participate as the Regulatory Affairs representative on clinical study teams
Perform regulatory tasks associated with Trial Master File activities
Lead or contribute to continuous improvement of regulatory processes and tools
Mentor less-experienced staff and serve as operational lead for priority programs or major submissions

Requirements

What you’ll need

Bachelor’s degree in a scientific or related discipline
5+ years of pharmaceutical, biotechnology, or related industry experience, including significant experience in regulatory affairs, regulatory submission management, or regulatory program support
Experience supporting global regulatory submissions and lifecycle management activities
Experience coordinating cross-functional regulatory deliverables
Experience managing complex timelines and dependencies
Experience driving operational execution across development and/or commercial programs
Working knowledge of U.S. regulatory requirements, submission processes, and IND/NDA lifecycle maintenance
Strong planning and organizational skills
Sound operational judgment and ability to escalate matters requiring regulatory or management decisions
Ability to anticipate delivery risks and develop mitigation plans
Effective cross-functional influence and communication
Strong documentation and quality-control skills, including attention to detail, version control, and submission readiness
Ability to guide and mentor less-experienced colleagues
Proficiency with document management systems, project planning tools, and standard office applications
Ability and willingness to travel approximately 10% of the year, domestically and internationally
Must live within commuting distance of the U.S. Corporate Headquarters in Florham Park, New Jersey
Office presence required at least 50% of each month

Benefits

Comp & perks

Comprehensive benefits
Bonus
Long-term incentive
Applicable allowances
Approximately 10% domestic and international travel