Senior Manager, Regulatory Program Support (RPS)

Shionogi Inc. • Florham Park, NJ

13d • $140,000 - $170,000 • Hybrid

About The Position

The Regulatory Program Support role provides operational and project support to regulatory teams across development programs and marketed products. It supports planning, coordination, and execution of regulatory deliverables so submissions and related activities are completed on time and in compliance with regulatory requirements. The role partners with the global regulatory lead and cross-functional teams and is accountable for the high-quality, efficient execution of assigned regulatory activities, including submission planning, documentation, tracking, and operational support for regulatory-authority interactions. Regulatory strategy, interpretation of health authority feedback, company positions, and material regulatory risk or trade-off decisions remain with the designated regulatory lead.

The Senior Manager works across Regulatory Affairs, including Development, CMC, Labeling, Advertising and Promotion, and Operations. The role reports to the Head of Regulatory Program Support and operates with limited oversight. It leads complex or multiple concurrent regulatory deliverables, identifies and resolves cross-functional execution risks, mentors less-experienced staff, and routinely serves as the RPS operational lead for priority programs or major submissions. The position requires travel of approximately 10% of the year, domestically and internationally. The employee must live within commuting distance of the U.S. Corporate Headquarters in Florham Park, New Jersey, and be present in the office at least 50% of the time each month.

Requirements

• Bachelor’s degree in a scientific or related discipline.
• At least 5 years of pharmaceutical, biotechnology, or related industry experience, including significant experience in regulatory affairs, regulatory submission management, or regulatory program support.
• Demonstrated experience supporting global regulatory submissions and lifecycle management activities, coordinating cross-functional regulatory deliverables, managing complex timelines and dependencies, and 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, including managing complex submission timelines, dependencies, and competing priorities.
• Sound operational judgment, with the ability to resolve execution issues independently and recognize when regulatory or management decisions require escalation.
• Ability to anticipate delivery risks, develop practical mitigation plans, and coordinate corrective actions across functions.
• Effective cross-functional influence and communication, including clarifying responsibilities, securing alignment, and communicating risks and recommendations.
• Accountability for timely, accurate, and compliant delivery of assigned regulatory activities.
• Strong documentation and quality-control skills, including attention to detail, version control, and submission readiness.
• Ability to guide and mentor less-experienced colleagues and improve regulatory processes and tools.
• Proficiency with document management systems, project planning tools, and standard office applications.
• Ability and willingness to travel approximately 10% of the year, both domestically and internationally.
• Must live within commuting distance of the U.S. Corporate Headquarters in Florham Park, New Jersey; office presence is required at least 50% of the time each month.

Nice To Haves

• Experience supporting global regulatory activities.

Responsibilities

• Account for end-to-end operational delivery of assigned submissions, including planning, coordination, document readiness, timeline and dependency management, tracking, and follow-up.
• Serve as the operational point of contact for designated applications and support IND/NDA lifecycle maintenance with the designated global regulatory lead; coordinate delegated application activities during the lead’s absence and escalate matters requiring interpretation, substantive approval, or company-position decisions.
• Develop and adjust submission and execution plans, sequence activities, and resolve routine cross-functional dependencies.
• Schedule regulatory submissions and support coordination, preparation, review, and submission of regulatory documents.
• Review documents for completeness, consistency, logic, readability, formatting, cross-references, hyperlink accuracy, submission readiness, and applicable technical requirements; substantive scientific or strategic approval remains with the document owner and regulatory lead.
• Contribute to major regulatory submission components, including drafting document sections and performing quality-control reviews of documents and embedded links.
• Perform regulatory archiving activities.
• Maintain regulatory timelines, trackers, and submission plans to support on-time milestone completion.
• Track regulatory action items, commitments, information requests, and post-submission activities.
• Lead operational cross-functional coordination for assigned deliverables, including scheduling meetings, preparing meeting materials and documentation, and assigning, tracking, and following up on action items.
• Create and maintain complex, cross-functional master timelines covering multiple deliverables, such as INDs, NDAs, and MAAs.
• Draft and maintain labeling components for assigned programs in alignment with agreed regulatory and labeling strategy.
• Perform quality-control reviews of labeling components; prepare and annotate components; and work with labeling committees to review, revise, and process labels through development, submission, approval, and implementation.
• Participate as the Regulatory Affairs representative on clinical study teams for defined operational and study-execution matters.
• Perform regulatory tasks associated with Trial Master File activities.
• Maintain risk logs and new investigator trackers.
• 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.
• Perform other duties as assigned.

Benefits

• The salary range excludes comprehensive benefits, bonus, long-term incentive, applicable allowances, and any additional compensation that may be associated with the role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior