Associate Director / Director, Regulatory Affairs -GDP Contractor

Overview

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

Responsibilities

• 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 antiviral 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

Assist in Managing Regulatory Risks and Developing Mitigation Strategies for Antiviral Initiatives SPECIFIC TASKS

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

SPECIFIC TASKS

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

ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS

MINIMUM QUALIFICATIONS TO THE JOB ASSIGNMENT SCOPE

TRAVEL REQUIREMENTS

HYBRID WORK POLICY FOR TEMPORARY ASSIGNMENTS

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 responsibilitiesmay change or be assigned at any time with or without notice.

Additional Information

The hourly rate position is $97 - $163. 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.

EEO

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.

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