Senior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool)

Please note - This position is part of a talent pool created in anticipation of future opportunities within our Regulatory team. Candidates may be considered for upcoming roles as business needs evolve. At Parexel, we are driven by a shared mission to help bring life‑changing therapies to patients globally. As a Regulatory Intelligence Senior Consultant, you will serve as a key strategic partner to clients, delivering timely, high‑quality regulatory intelligence that supports informed development decisions and sustained regulatory compliance. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams. As a Regulatory Intelligence Sr. Consultant, you will:

• Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
• Regularly search the public domain for competitor product regulatory developments and report the most critical findings
• Inform client immediately of any changes to the regulatory environment directly affecting client’s business
• Search for non-compliance letters or notices for client’s suppliers and provide a regular report
• Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
• Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
• Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
• Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

Qualifications:

• At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
• Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
• A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
• Project management / leadership experience
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work (Quality)
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

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