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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