Senior Manager, Regulatory Program ; RPS

The Regulatory Program Support role provides operational and project support to regulatory teams across development programs and marketed products. This role supports the planning, coordination, and execution of regulatory deliverables, ensuring submissions and related activities are completed on time and in compliance with regulatory requirements.

This individual 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 interactions with regulatory authorities. Regulatory strategy, interpretation of health authority feedback, determination of company positions, and material regulatory risk or trade-off decisions remain with the designated regulatory lead.

A successful candidate will thrive in a fast-paced environment; possess effective communication, interpersonal, and organizational skills; and demonstrate the ability to adapt to changing priorities. The candidate should be a quick and curious learner who can shift priorities as needed. This role will work with all areas of Regulatory Affairs (i.e., Development, CMC, Labeling, Advertising and Promotion, and Operations).

This role reports to the Head of Regulatory Program Support. The Senior Manager operates with limited oversight, 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.

• Accountable for the end-to-end operational delivery of assigned submissions, including submission planning, coordination, document readiness, timeline and dependency management, tracking, and operational follow-up.
• Serves as the operational point of contact for designated applications and supports IND/NDA lifecycle maintenance in partnership with the designated global regulatory lead. During the lead’s absence, coordinates application-related activities within delegated responsibilities and escalates matters requiring regulatory interpretation, substantive approval, or company-position decisions.
• Develops and adjusts regulatory submission and execution plans, sequences activities, and resolves routine cross-functional dependencies.
• Schedules regulatory submissions and supports the coordination, preparation, review, and submission of regulatory documents.
• Performs defined document reviews for completeness, consistency, logic, readability, formatting, cross-references, hyperlink accuracy, submission readiness, and applicable technical requirements. Substantive scientific or strategic content approval remains with the designated document owner and regulatory lead.
• Contributes to the development of components of major regulatory submissions (e.g., drafts document sections and performs quality control reviews of documents and embedded links).
• Performs regulatory archiving activities.
• Maintains regulatory timelines, trackers, and submission plans to ensure the on-time completion of milestones.
• Tracks regulatory action items, commitments, information requests, and post-submission activities.
• Leads the operational aspects of cross-functional coordination for assigned regulatory deliverables, including scheduling meetings, preparing meeting materials and documentation, and assigning, tracking, and following up on action items.
• Creates and maintains complex, cross-functional, multiple-deliverable master timelines (e.g., INDs, NDAs, and MAAs).
• Drafts and maintains labeling components for assigned programs, in alignment with the agreed regulatory and labeling strategy
• Performs QC reviews of all labeling components; prepares and annotates labeling components; and works with labeling committees to review, revise, and process label components through development, submission, approval, and implementation.
• Participates as the Regulatory Affairs representative on clinical study teams for defined operational and study-execution matters.
• Performs regulatory tasks associated with Trial Master File activities.
• Maintains risk logs and new investigator trackers.
• Leads or contributes to the continuous improvement of regulatory processes and tools.
• Other duties as assigned.

Qualifications

• Bachelor's degree in a scientific or related discipline
• 5+ years of pharmaceutical, biotechnology, or…