Regulatory Affairs Officer

vor 1 Monat

Melbourne, Österreich Iqvia Argentina Vollzeit

Are you ready to make a significant impact in the world of clinical research? As a Regulatory Affairs Specialist, you'll be at the forefront of ensuring the wellbeing of clinical research subjects and driving exceptional project outcomes. You'll be the go-to expert for preparing and reviewing regulatory submissions, securing marketing authorizations applications and lifecycle management. Your role will be pivotal in shaping the future of healthcareThis role can be based anywhere in Australia. This position is not open to Sponsorship. As part of the interview process, you will be asked to complete video screening.Key Responsibilities:Regulatory Submissions: Prepare and submit applications for marketing authorization and lifecycle management to the TGA. Ensure that all submissions are complete, properly formatted, and comply with current regulatory standards.Regulatory Strategy: Develop and implement regulatory strategies for the approval of new biologics. This includes understanding the regulatory landscape, identifying potential challenges, and developing plans to address them.Cross-Functional Collaboration: Work closely with cross-functional teams including Research & Development, Quality Assurance, and Manufacturing to ensure alignment on regulatory requirements.Regulatory Compliance: Ensure compliance with all relevant regulations and guidelines. This includes staying up to date with changes in regulatory requirements and updating internal processes accordingly.Document Excellence: Prepare and review top-notch regulatory documentation in your area of expertise.Customer Champion: Build and nurture strong relationships with customers, addressing regulatory issues and sharing valuable insights.Subject Matter Expert: Shine as an SME in areas like Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Publishing.Project Maestro: Master the Scope of Work, deliverables, and budget management for projects, ensuring seamless execution.Mentor and Guide: Provide invaluable guidance to junior colleagues, offering feedback on technical documents and supporting their growth.Client Presenter: Impress clients with your knowledge of complex regulatory processes during bid defense meetings.SOP Reviewer: Review and refine regulatory standard operating procedures to maintain high standards.Training Guru: Deliver engaging regulatory training sessions to small groups or individuals within the organization.Versatile Contributor: Take on additional tasks or assignments as delegated by Regulatory management, showcasing your adaptability.Minimum Required Education and Experience:Experience: Bring your 2-3 years of relevant experience to the table and make a difference.Knowledge: Leverage your intermediate level knowledge of regulatory principles, theories, and concepts, gained through advanced education and experience.Education:Bachelor's Degree in Lifescience or related discipline (required)Master's Degree in Lifescience or related discipline (preferred)Additional Work Experience: At least 3-4 years of relevant experience (preferred).Skills and Abilities:R&D Savvy: Deep understanding of the Research and Development process, including Chemistry, Manufacturing & Controls, Preclinical and Clinical, laws, and guidelines.Regulatory Expertise: Possess specific regulatory or technical expertise that sets you apart.Communication Pro: Excellent interpersonal communication (oral and written) and organizational skills.Relationship Builder: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.Tech-Savvy: Proficiency in Microsoft Office and publishing applications.Self-Starter: Demonstrates self-motivation and enthusiasm.Multi-Tasker: Ability to juggle multiple projects with direction from senior staff.Process Improver: Consistently follow standard operating procedures and contribute to process improvements.Decision Maker: Ability to make decisions on discrete tasks under senior supervision.Advanced Knowledge: Advanced knowledge within a specific discipline, gained through extensive work experience and/or education.Problem Solver: Make adjustments or recommend enhancements in systems and processes to solve problems or improve job area effectiveness.
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