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. 

Responsibilities

• 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.

Minimum Job Requirements

Qualifications

• 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.
• 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 is a must; experience supporting global regulatory activities is preferred.

Competencies

• Strong planning and organizational skills, including the ability to manage 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 the ability to clarify responsibilities, secure alignment, and communicate 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.

Other Requirements

• This role does not have direct supervisory responsibility
• Ability and willingness to travel approximately 10% of the year, both domestically and internationally
• Must live within commuting distance of our U.S. Corporate Headquarters in Florham Park, NJ. Office presence is required at least 50% of the time each month

Additional Information

The base salary range for this full-time position is $140,000 - $170,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.