Senior Regulatory Strategist, Advertising & Promotion (work from home)
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战略家，广告和推广人员以远程身份加入我们的团队。作为一位高级监管策略师，广告与推广人员，你将担任支持临床研究和促进患者新的治疗活动的商业顾问。这一职位在确保监管合规，解释 FDA 指导以及提供塑造产品战略的战略监管见解方面发挥着关键作用。你将与包括医疗事务，法律，商业和营销在内的跨职能团队合作，遵循行业标准的监管流程，并从策略开发到实施中为监管卓越贡献。责任包括提供广告和促销材料的战略监管指导，独立审查和批准宣传内容，解释不断发展的 FDA 指导方针，以深化你的专业知识和影响整个组织的监管战略。你将加入一个快速发展，增长型环境，重点关注通过战略监管领导产生有意义的影响。
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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.
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 Strategist, Advertising & Promotion to join our team in a remote capacity. As a Senior Regulatory Strategist, Advertising & Promotion, you will serve as a trusted regulatory advisor supporting clinical research and commercial activities that advance new treatments for patients. This position plays a key role in ensuring regulatory compliance, interpreting FDA guidance, and delivering strategic regulatory insights that shape product strategy. You'll collaborate with cross-functional teams including Medical Affairs, Legal, Commercial, and Marketing, follow industry-standard regulatory processes, and contribute to regulatory excellence from strategy development through implementation. Responsibilities include providing strategic regulatory guidance on advertising and promotional materials, independently reviewing and approving promotional content, and interpreting evolving FDA guidance, with opportunities to deepen your expertise and influence regulatory strategy across the organization.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership, risk mitigation, and advancing patient safety. With diverse teams and continuous learning opportunities, the Senior Regulatory Strategist, Advertising & Promotion can explore career paths and expand skills across regulatory affairs and clinical research.
Key Responsibilities
· Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
· Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
· Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards
· Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
· Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
· Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
· Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
· Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
· Support and, where needed, lead regulatory review committees, driving efficient and compliant review processes
· Stay current with regulatory trends, FDA enforcement actions, and industry best practices, proactively sharing insights with internal stakeholders
· Mentor junior team members and contribute to building organizational regulatory capability
Candidate Profile
You'll thrive in this role if you bring:
· Deep knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
· Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
· Strong experience collaborating with Medical Affairs, Legal, and Commercial teams
· Demonstrated ability to independently review promotional materials and make sound regulatory decisions
· Excellent communication, influence, and stakeholder management skills
· Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
Required Qualifications
· 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
· Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
· Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
· Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
· Demonstrated ability to independently review promotional materials and make sound regulatory decisions
· Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
· Excellent communication, influence, and stakeholder management skills
· Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
Preferred Qualifications
· Experience supporting product launches or high-visibility brands
· Familiarity with global regulatory considerations
· Prior experience leading or facilitating regulatory review committees
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