Senior Regulatory Affairs Associate - Regulatory Intelligence

About the Role

We are seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence to join our team in a remote capacity. As a Senior Regulatory Affairs Associate, Regulatory Intelligence, you will support clinical research activities that advance new treatments for patients by keeping our teams informed about the global regulations, guidance, and standards that shape how medicines are developed. This position plays a key role in regulatory compliance and in understanding how regulatory change affects products, development pipelines, and business operations. You'll collaborate with subject matter experts, follow industry-standard processes, and lead the global implementation of impact assessments from identification through reporting.

Key Responsibilities

• Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies.
• Review regulatory content for relevance, distribute approved content to key stakeholders for impact assessment and gap analysis, and regularly review and update stakeholder distribution lists.
• Collaborate with company subject matter experts to assess the implications of regulatory changes on the company's products, development pipelines, and business operations.
• Maintain communication with key stakeholders across the company to track the implementation of impact assessments and gap analyses.
• Analyze and report impact assessment compliance metrics, and follow up with stakeholders on actions to minimize risks.
• Use the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content, and regularly review and update AI taxonomy terms for approved and investigational products, clinical programs, and business development programs.
• Participate in audits and inspections as needed, supplying evidence of regulatory intelligence tracking and impact assessment analysis.
• Maintain familiarity with global standard operating procedures (GSOPs) and working procedures (WPs) in the document management system.
• Maintain close communication with Information Technology, Regulatory Technology, and the regulatory intelligence platform vendor to triage technical problems, access requests, and distribution issues.
• Demonstrate understanding of major regional and global industry association priorities, such as those of PhRMA, EFPIA, and JPMA.
• Apply solid working knowledge of drug, biologic, and device development processes, laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH.
• Stay current with emerging trends and technologies in regulatory intelligence, sharing learnings to continuously improve company compliance activities.

Candidate Profile

• Strengths in project planning, coordination, and critical thinking
• Experience working in clinical research, healthcare, or a regulated environment
• The ability to collaborate across teams and communicate clearly
• A commitment to compliance and strong attention to detail when tracking regulatory change
• Comfort working with an AI-enabled regulatory intelligence platform, document management systems, and Microsoft Office

Required Qualifications

• Minimum of 2 years of work experience in regulatory intelligence
• Bachelor's degree in a scientific or technical discipline
• Previous experience analyzing and reporting compliance metrics
• Solid working knowledge of drug, biologic, and device development processes, and of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH
• Ability to plan, direct, organize, and coordinate projects
• Excellent interpersonal skills, with strong written and verbal communication
• Critical thinking and problem-solving skills
• Results-driven, team-oriented collaborative approach
• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications

• Minimum of 2 years of regulatory affairs experience
• Previous interactions with the FDA or other health authorities
• Previous experience with pharmacovigilance or regulatory work in pharmacovigilance
• Previous experience developing newsletters