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Senior Regulatory Affairs Consultant - Post-Approval Regulatory Strategy Lead
Primary Location: United States, Remote Job ID R0000035930 Category Regulatory Affairs Date Posted 10/08/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Join Parexel as a Post-Approval Regulatory Strategy Lead!
Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs? Do you thrive in cross-functional environments and love transforming regulatory requirements into actionable plans? If so, we’d love to connect.
We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for developing and executing global regulatory strategies for our clients’ marketed products, ensuring continued compliance and lifecycle optimization across multiple regions. You’ll serve as a key liaison between cross-functional teams and global health authorities, driving regulatory excellence and innovation in post-marketing activities.
Key Responsibilities
• Develop and lead global post-approval regulatory strategies for assigned products, ensuring alignment with business objectives and regulatory requirements.
• Serve as the primary regulatory contact for marketed products, managing interactions with global health authorities (e.g., FDA, EMA, PMDA, Health Canada).
• Oversee the preparation, submission, and maintenance of post-approval regulatory filings, including variations, supplements, renewals, and annual reports.
• Collaborate cross-functionally with CMC, clinical, safety, labeling, and commercial teams to support product lifecycle management.
• Monitor evolving regulatory landscapes and proactively assess impact on existing products and strategies.
• Provide regulatory guidance during change management processes and ensure timely implementation of regulatory commitments.
• Represent Regulatory Affairs in internal governance forums and external regulatory meetings as needed.
Qualifications
• Bachelor’s degree in life sciences, pharmacy, or a related field (advanced degree preferred).
• Minimum of 7 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with a strong focus on post-approval activities.
• Proven track record of successful global regulatory submissions and interactions with health authorities.
• Deep understanding of global regulatory frameworks (ICH, FDA, EMA, etc.) and post-marketing requirements.
• Excellent project management, communication, and leadership skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Strong communication, leadership, and collaboration skills.
• Detail-oriented mindset with a proactive approach to problem-solving.
• Willingness to travel 15-20%, if needed, in a global work environment.
Why You’ll Love Working Here
• Work with both passionate, mission-driven colleagues and client teams
• Influence global development programs that make a difference
• Enjoy flexible work arrangements and a collaborative culture
• Stay ahead of the curve with cutting-edge regulatory tools and training
• Be part of a company that values innovation, integrity, and impact
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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