Regulatory Affairs Consultant - FSP
当我们的价值观一致时，我们能达到什么样的目标都没有限制。在 Parexel,我们都有相同的目标 - - 改善世界健康。从临床试验到监管，咨询和市场准入，我们提供的每一个临床开发解决方案都是基于某种特殊的东西 - - 我们对所做的深厚信念。无论我们在 Parexel 做什么，我们每个人都有助于发展一种治疗最终会有益于患者。我们把工作作为个人，我们以同情感而做，我们致力于改变。拥有并制定监管战略跨着重要的计划或投资组合，确保与业务目标和监管要求保持一致。提供有关主要监管决策的领导力，包括当局参与模式，提交战略和风险减轻方法领导高影响监管提交计划和执行，协调跨职能团队并确保遵守监管要求制定和实施长期发展和生命周期管理方案，优化监管途径和商业成果与临床，科学和商业团队合作，将监管战略与开发时间表和市场机会结合。关键要求 · 支持澳大利亚产品开发和生命周期管理的重大监管事务经验。· 有证实领导或支持 HA 互动和监管程序的经验。• 对营销许可申请 (MAA) 和 CTD/eCTD 档案要求的强烈了解。· 准备和审查监管文件，包括模块1内容和卫生当局简报材料的经验；· 在监管战略制定，档案审查和卫生机构参与方面证明了专业知识。· 优秀的项目领导能力，利益相关者管理和沟通技能。· 能够在快速发展的环境中管理多项监管优先事项，同时提供高质量的成果的能力。技能：·项目管理知识 ·客户专注的工作方法 ·结果导向 ·团队合作和协作能力 ·咨询技巧 ·书面和口头交际和跨文化沟通能力 ·批判性思维和解决问题的能力 ·当地语言和地区语言的熟练度
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Own and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements
Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches
Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements
Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes
Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities
Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches
Key Requirements
- Significant Regulatory Affairs experience supporting Australian product development and lifecycle management.
- Proven experience leading or supporting HA interactions and regulatory procedures.
- Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements.
- Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials.
- Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement.
- Excellent project leadership, stakeholder management, and communication skills.
- Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment.
Skills:
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language
Knowledge and Experience:
· At least 7+ years of experience in an industry-related environment with a deep Australia regulatory expertise
Education:
· Minimum of a Bachelor’s Degree in a Scientific or related area of study
Originally posted on Himalayas