Senior Regulatory Affairs Associate - Regulatory Intelligence

Parexel•Southport, NC

5d•Remote

About The Position

Parexel is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence, to support clinical research by keeping teams informed about global regulations, guidance, and standards that shape medicine development. The role supports regulatory compliance and evaluates how regulatory changes affect products, development pipelines, and business operations. It involves collaborating with subject matter experts and leading global implementation of impact assessments from identification through reporting. The position is remote and offers opportunities to deepen regulatory intelligence expertise and influence how regulatory change is managed. The role operates in a fast-paced, growth-oriented environment, with a focus on timely identification of regulatory change, rigorous impact assessment, and clear reporting to support compliance across the business. The associate will work with diverse teams and use an AI-enabled regulatory intelligence platform and related tools.

Requirements

At least 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 laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH.
Ability to plan, direct, organize, and coordinate projects.
Excellent interpersonal skills and strong written and verbal communication.
Critical-thinking and problem-solving skills.
Results-driven, team-oriented collaborative approach.
Strong demonstrated experience with Microsoft Office programs, including Word, Excel, PowerPoint, and Outlook.
Strengths in project planning, coordination, and critical thinking.
Experience working in clinical research, healthcare, or a regulated environment.
Ability to collaborate across teams and communicate clearly.
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.

Nice To Haves

At least 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.

Responsibilities

Monitor the regulatory intelligence platform and other 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 stakeholders for impact assessment and gap analysis; and review and update stakeholder distribution lists.
Collaborate with subject matter experts to assess the effects of regulatory changes on products, development pipelines, and business operations.
Communicate with stakeholders across the company to track 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 review and update AI taxonomy terms for approved and investigational products, clinical programs, and business development programs.
Participate in audits and inspections as needed by supplying evidence of regulatory intelligence tracking and impact assessment analysis.
Maintain familiarity with global standard operating procedures and working procedures in the document management system.
Communicate with Information Technology, Regulatory Technology, and the regulatory intelligence platform vendor to triage technical problems, access requests, and distribution issues.
Demonstrate understanding of regional and global industry association priorities, including those of PhRMA, EFPIA, and JPMA.
Apply working knowledge of drug, biologic, and device development processes and relevant laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH.
Stay current with emerging trends and technologies in regulatory intelligence and share learnings to improve company compliance activities.