Senior Regulatory Affairs Associate - Regulatory Intelligence

Regulatory Toolkit; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence to join our team in a remote capacity. You will support regulatory compliance and track global regulations across drugs, biologics, and devices, influencing development pipelines and business operations.

You will collaborate with SMEs, lead impact assessments, and use AI-enabled platforms to summarize content, while maintaining documentation and contributing to audits.

Qualifications

• 2+ years of work experience in regulatory intelligence.
• Bachelor's degree in a scientific or technical discipline.
• Knowledge of FDA, EMA, PMDA, ICH guidelines and drug development processes.
• Ability to plan, direct, organize, and coordinate projects.
• Excellent written and verbal communication skills.

Responsibilities

• Monitor the regulatory intelligence platform and global sources to identify regulations, guidelines, and policies.
• Review regulatory content for relevance and distribute it for impact assessment and gap analysis.
• Collaborate with subject matter experts to assess regulatory changes' implications on products and pipelines.
• Maintain stakeholder communication to track implementation of impact assessments.
• Analyze compliance metrics and follow up on actions to minimize risks.
• Utilize AI-enabled tools to tag and summarize GxP-content and update taxonomy.
• Participate in audits and inspections with evidence of regulatory tracking.
• Stay familiar with GSOPs/WPs in the document management system.
• Coordinate with IT, Regulatory Technology, and platform vendors to address issues.
• Demonstrate knowledge of priorities from PhRMA, EFPIA, JPMA.
• Keep up-to-date with trends in regulatory intelligence and inform the business.

Skills

Project planning

Coordination

Critical thinking

Communication

Regulatory intelligence

Microsoft Office

Team collaboration

Education

Bachelor's degree in a scientific or technical discipline

Tools

AI-enabled regulatory platform

Document management systems

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

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. Responsibilities include overseeing the tracking and distribution of regulations and guidance relevant to all Good Practice (GxP) areas, with opportunities to deepen your expertise and influence how regulatory change is managed.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through timely identification of regulatory change, rigorous impact assessment, and clear reporting that supports compliance across our business. With diverse teams and continuous learning opportunities, the Senior Regulatory Affairs Associate, Regulatory Intelligence can explore career paths and expand skills across regulatory intelligence and clinical research.

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 the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Japan Pharmaceutical Manufacturers Association (JPMA).
• Apply solid working knowledge of drug, biologic, and device development processes, laws, regulations, and guidelines from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and International Council for Harmonization (ICH).
• Stay current with emerging trends and technologies in regulatory intelligence, sharing learnings to continuously improve company compliance activities.

Candidate Profile

You'll thrive in this role if you bring:

• 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 approachStrong 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

Benefits and Compensation

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.