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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.

\#LI-LB1

\#LI-REMOTE

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.

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Senior Regulatory Strategist, Advertising & Promotion (work from home)