Dir, US Regulatory Affairs, GDP (Finance)

Overview
Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specific regions
Responsibilities
SPECIFIC TASKS

• 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.
• Contribute to the preparation and submission of regulatory documents related to antimicrobial/ antifungal programs to regulatory authorities.
• Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights.

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

SPECIFIC TASKS

• 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.

Assist in Managing Regulatory Risks and Developing Mitigation Strategies for Anti-Infective InitiativesSPECIFIC TASKS

• 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.

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

SPECIFIC TASKS

• 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.

Assist in Preparing Regulatory Updates, Progress Reports, and Strategic Recommendations for Senior LeadershipSPECIFIC TASKS

• 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.

ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS

• Specific projects to be completed include:
• preparation of Type C/B/D Meetings for antimicrobials in clinical development (as needed)
• contributions to/ finalization of regulatory strategy plans for antimicrobials in development
• preparation of sNDA for marketed antimicrobial
• Knowledge of and Compliance with FDA, EMEA, PMDA guidances
• Performance will be monitored via regularly review by the GTAL 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 GTAL Regulatory Affairs will review and approve completed work.

MINIMUM QUALIFICATIONS TO THE JOB ASSIGNMENT SCOPE

• 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.

TRAVEL REQUIREMENTS

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

HYBRID WORK POLICY FOR TEMPORARY ASSIGNMENTS

• 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
Shionogi Inc. is an equal opportunity/affirmative action employer.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.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.