Regulatory Intelligence Senior Associate (Biological products)

Responsibilities

• Continuously track and evaluate new and updated regulations, guidelines, and standards issued by health authorities.
• Conduct impact assessments to determine how regulatory changes affect products, filings, labeling, and clinical requirements.
• Translate complex regulatory updates into clear, concise summaries and actionable recommendations for global and local teams.
• Provide regulatory insights to support strategy development, risk assessment, and decision-making for registrations and compliance activities.
• Deliver regular regulatory intelligence briefings, newsletters, and alerts to keep internal stakeholders informed.
• Actively participate in industry associations, regulatory intelligence networks, and specialist working groups.
• Partner with cross-functional teams including Quality, Pharmacovigilance, and Medical Affairs to embed intelligence into operational planning.

Requirements

• Bachelor’s Degree in a Scientific Discipline.
• Proven experience in Regulatory Intelligence.
• Direct experience working with Biological products.
• Fluency in both English and Spanish.
• Strong understanding of LATAM and/or global regulatory frameworks, laws, and procedures.
• Exceptional written and verbal communication skills with the ability to explain complex concepts to non-experts.

Preferred Qualifications

• Experience with regulatory intelligence tools, databases, and scientific information sources.
• Ability to synthesize large volumes of information into strategic insights for diverse audiences.
• Proactive approach to professional networking and continuous learning within the regulatory field.

Benefits

• Flexible remote work arrangements.
• Opportunities for career growth through challenging assignments and mentorship from experienced professionals.
• Exposure to diverse product types and global therapeutic areas.
• A supportive and inclusive team environment focused on collaboration and innovation.

About the Company

Parexel is a global leader in clinical research, dedicated to helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We combine scientific expertise with empathy to bring life-changing products to market faster, always keeping the patient at the heart of everything we do.