Senior Regulatory Affairs Associate - CTA Senior Specialist
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，我们提供的每种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 Parexal 做什么，我们每个人都有助于开发一种治疗最终会有益于患者。我们把工作视为个人，我们以同情感而做，并致力于改变生活。关于 Parexel 帕雷克塞尔是全球领先的临床开发合作伙伴，为生命科学行业提供基于见解的临床和咨询解决方案。我们在全球拥有22,000多名员工，与生物制药公司和研究网站合作设计和交付专注于患者的临床试验，使研究成为任何人都可以获得的医疗服务选择。我们以关注力，灵活性和共享目的工作 - - 紧急地应对患者需求并加速新治疗。我们拥抱大胆思考，快速适应变化，不断提高临床研究速度和质量水平。我们正在扩大我们的团队，并寻找有才华的个人来帮助推动行业领先的创新，With Heart(R).关于角色我们正在寻求一名高级监管事务副主任 - CTA 高级专家加入我们的团队以远程能力。作为高级监管问题副主任-CTA 高级专家，你将支持临床试验授权提交和全球患者推进新的治疗活动的关键临床试用许可证申请和监管合规活动。这一职位在 CTA （临床试题应用）战略开发，提交执行，监管机构互动以及确保质量和遵守全球提交中发挥着重要作用。你将与跨职业团队合作，遵循行业标准的流程，并从计划到完成之前为监管提交贡献。责任包括准备和协调全球 CTA 文档，管理向卫生当局提交的文件，实施监管战略，并保持遵守不断变化的监管要求。通过多种团队和持续学习机会，这个角色提供了深入监管事务方面的专业知识和影响创新疗法的前进道路的机会。关键责任 · 提供运营能力
查看英文原文
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.
About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).
About the Role
We are seeking a Senior Regulatory Affairs Associate - CTA Senior Specialist to join our team in a remotecapacity. As a Senior Regulatory Affairs Associate - CTA Senior Specialist, you will support critical clinical trial authorization submissions and regulatory compliance activities that advance new treatments for patients worldwide. This position plays a key role in CTA (Clinical Trial Application) strategy development, submission execution, regulatory authority interactions, and ensuring quality and compliance across global submissions. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory submissions from planning through closeout.
Responsibilities include preparing and coordinating global CTA documentation, managing submissions to health authorities, implementing regulatory strategy, and maintaining compliance with evolving regulatory requirements. With diverse teams and continuous learning opportunities, this role offers the chance to deepen your expertise in regulatory affairs and influence the path forward for innovative therapies.
Key Responsibilities
· Provide operational and regulatory support for CTA submissions and maintenance activities, ensuring compliance with all applicable requirements
· Prepare and coordinate global CTA and amendment documentation, managing dossier development and ensuring quality and completeness
· Manage or facilitate submissions to health authorities or via local personnel, serving as the primary point of contact for regulatory interactions
· Liaise with and oversee CROs for submissions and query management, ensuring timely and accurate responses to regulatory inquiries
· Implement global CTA strategy and ensure quality and compliance to country-specific requirements across all regulatory submissions
· Maintain tracking and archiving of regulatory submissions while communicating EU regulatory requirements and updates to cross-functional teams
· Contribute to process improvements that enhance efficiency and quality in regulatory submission management
Candidate Profile
You'll thrive in this role if you bring:
· Proven leadership in EU CTA documentation and submissions with demonstrated success managing complex regulatory processes
· Strong knowledge of EU drug development, CTR, and CTIS workflows with ability to apply regulatory expertise across multiple jurisdictions
· Project management and leadership skills with ability to coordinate cross-functional teams and manage vendor relationships
· Excellent communication and cross-functional collaboration skills with ability to influence and drive results across organizational boundaries
· Experience working in clinical research, healthcare, or a regulated environment with strong attention to detail and quality mindset
Required Qualifications
· Bachelor's degree in Life Science or equivalent experience
· 6+ years in pharmaceutical industry with 5+ years in Regulatory Affairs
· Strong knowledge of EU drug development, CTR, and CTIS regulatory frameworks
· Demonstrated experience with CTA submission processes and regulatory compliance
· Strong communication, organization, and problem-solving skills
Preferred Qualifications
· Advanced degree in Life Science, Regulatory Affairs, or related field
· Familiarity with regulatory submission tracking systems and electronic document management tools
· Knowledge of additional regulatory pathways beyond EU requirements
Benefits and Compensation
· Health, Vision & Dental Insurance
· Tuition Reimbursement
· Vacation/Holiday/Sick Time
· Flexible Spending & Health Savings Accounts
· Work/Life Balance
· 401(k) with Company match
· Pet Insurance
For a complete list of benefits, please visit www.parexel.com/us-benefits.
Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Originally posted on Himalayas