Associate Director/Director, Regulatory Affairs - Global Development Products - Anti- Infectives - Contractor

Overview:

This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our antiviral initiatives.

Responsibilities:

1. Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions

• Assisting in preparing presentations, reports, and strategic documents for leadership discussions.
• Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure smooth execution.
• Organizing and documenting meeting minutes and action items to support the leader’s strategic planning.
• Contributing to the preparation and submission of regulatory documents related to antivral programs to regulatory authorities.
• Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights.

1. Assist in Coordinating Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans

• Maintaining centralized regulatory meeting minutes to track planning and progress of key submissions, including timelines, status updates, and regulatory requirements across regions.
• Scheduling and organizing cross-functional and cross-regional meetings, preparing agendas, and summarizing discussions.

1. Assist in Managing Regulatory Risks and Developing Mitigation Strategies for Antiviral Initiatives

• Maintaining a regulatory risk log, tracking identified risks, mitigation plans, and follow-up actions.
• Conducting literature reviews and research on regulatory guidelines to provide preliminary insights.
• Drafting initial risk assessment summaries for leadership to review and refine.

1. Provide Regulatory Guidance and Support for Post-Marketing Activities Related to Marketed Anti-Infectives

• Assisting in preparing draft regulatory documents under the guidance of senior regulatory staff.
• Tracking post-marketing requirements and submission deadlines to ensure compliance.
• Conducting basic document reviews for formatting, consistency, and completeness before submission.
• Compiling and organizing historical regulatory data for reference and audits.

1. Assist in Preparing Regulatory Updates, Progress Reports, and Strategic Recommendations for Senior Leadership

• Gathering regulatory intelligence and compiling data for leadership reports.
• Assisting in drafting initial versions of regulatory updates, subject to review and refinement.
• Creating visual summaries, presentations, and dashboards to convey regulatory insights effectively.
• Maintaining a library of past regulatory updates for reference and consistency.

• Specific projects to be completed include:
• preparation of Type C/B/D Meetings for antivirals in clinical development (as needed)
• contributions to and finalization of regulatory strategy plans and implementation for antivirals in development (including 2 new IND applications and 1 NDA)
• Knowledge of and Compliance with FDA, EMEA, PMDA guidances
• Performance will be monitored via regular review by the Executive Director and feedback on the strategist's work. This will include review of meeting minutes, timelines and draft submission packages. Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality of submissions
• The Executive Director, Regulatory Affairs will review and approve completed work.

• Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
• 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred.
• Demonstrated ability to work effectively in a cross-functional team environment.
• Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
• Excellent communication and interpersonal skills.

• Percentage or frequency of travel: this position may require up to approx. 10% domestic and/or international traveling

• - Must live within a commutable distance to our US Corporate Headquarters located in Florham Park, NJ. Office presence is required at least 50% of the time per month.

EEO:

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

You can request accomodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.