Senior Regulatory Affairs Associate (Regulatory Intelligence)

Join Parexel as a Senior Regulatory Affairs Associate (Regulatory Intelligence) within one of our strategic, long‑term client partnerships, where your expertise will directly shape how a global organization anticipates and responds to evolving regulatory expectations. This high‑visibility role places you at the center of a deeply collaborative client environment, continuously monitoring, analyzing, and translating local, regional, and global regulatory developments into clear, actionable insights for both regulatory teams and internal stakeholders.

If you thrive on staying ahead of change, are passionate about continuous learning, and excel at guiding others through complex regulatory nuance, this role offers the opportunity to make a meaningful impact across the client’s global network. You will actively engage in regulatory meetings, industry forums, and key conferences—bringing back critical intelligence that informs forward‑looking regulatory strategies and strengthens best‑practice alignment.

Step into a position where influence, collaboration, and purpose come together—at the heart of a dedicated client partnership.

Key Accountabilities:

Regulatory Intelligence Monitoring & Analysis

• Continuously track and evaluate new and updated regulations, guidelines, standards, and procedural changes issued by health authorities across assigned regions.

• Conduct impact assessments to determine how regulatory changes may affect the organization’s products, filings, labeling, clinical requirements, and lifecycle strategies.

Communication & Cross-Functional Support

• Translate complex regulatory updates into clear, concise summaries and recommendations for Global Regulatory Affairs and local country teams.

• Provide regulatory insights to support strategy development, risk assessment, and decision‑making for new registrations, variations, renewals, and compliance activities.

• Deliver regular regulatory intelligence briefings, newsletters, and alerts to keep teams informed of relevant changes.

External Engagement & Networking

• Actively participate in industry associations, regulatory intelligence networks, specialist working groups, and national or regional regulatory forums.

• Attend conferences, workshops, and meetings with regulatory authorities to stay informed about evolving expectations and to gather real‑world interpretations of new requirements.

• Share knowledge gained from external engagements to enhance organizational awareness and maintain best‑practice standards.

Internal Collaboration & Strategic Contribution

• Partner with Global and Local Regulatory Affairs, Quality, Pharmacovigilance, Medical Affairs, and other functions to embed regulatory intelligence insights into operational planning.

• Support the development of regional regulatory strategies, considering anticipated regulatory trends and innovation pathways.

• Contribute to regulatory risk mitigation plans, scenario forecasting, and strategic recommendations for market access or lifecycle management.

Key Skills & Competencies

Technical Skills

• Strong understanding of LATAM and/or global regulatory frameworks, laws, and procedures.

• Ability to interpret guidelines and policy documents and translate them into operational and strategic impact.

• Experience with regulatory intelligence tools, databases, and scientific/regulatory information sources.

Analytical & Strategic Skills

• Excellent ability to analyze regulatory trends, assess impacts, and identify risks or opportunities.

• Strong skills in critical thinking, problem‑solving, and anticipating regulatory expectations.

• Ability to synthesize large volumes of information into clear insights for diverse audiences.

Communication & Collaboration

• Exceptional written and verbal communication skills, capable of explaining regulatory concepts to non‑experts.

• Ability to collaborate effectively across global and local teams and influence decision‑making.

• Skilled in preparing high‑quality presentations, summaries, and strategic updates.

Leadership & Professional Engagement

• Proactive, curious, and highly engaged in continuous learning and professional networking.

• Comfortable representing the organization in external meetings, conferences, and industry groups.

• Strong commitment to compliance, quality, and regulatory excellence.

Knowledge and Experience:

• Initial years of experience in an industry-related environment

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

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