Associate Director/Director, Regulatory Affairs -GDP Contractor

About the positionResponsibilities• 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. • 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. • 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. • 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.• 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. Requirements• 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. Benefits• Hourly rate position is $97 - $163. • Individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Apply tot his job