Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Regulatory Compliance Cross-Functional Collaboration Regulatory Compliance Government Regulation Analysis Lifecycle Management Hazard Analysis Regulatory Compliance Market Access Strategy Regulatory Compliance Stakeholder Communications Presentation Training Microsoft Networking

Other Skills

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Non-Verbal Communication
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Analytical Skills
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Teamwork
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Critical Thinking
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Problem Solving

Roles & Responsibilities

University Degree in a Scientific or Technical Discipline
Strong understanding of EU regulatory frameworks, laws, and procedures, with the 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; ability to analyze regulatory trends and identify risks or opportunities
Excellent written and verbal communication skills, including the ability to explain regulatory concepts to non-experts; fluent in English

Requirements:

Continuously track and evaluate new and updated regulations, guidelines, standards, and procedural changes issued by health authorities across assigned regions; conduct impact assessments on how regulatory changes may affect products, filings, labeling, clinical requirements, and lifecycle strategies
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 registrations, variations, renewals, and compliance activities
Actively participate in regulatory intelligence networks, industry associations, specialist working groups, and regulatory forums; attend conferences and meetings with regulatory authorities to stay informed and share knowledge gained from external engagements to enhance organizational awareness and best-practice standards
Partner with Global and Local Regulatory Affairs, Quality, Pharmacovigilance, Medical Affairs, and other functions to embed regulatory intelligence insights into operational planning and regional strategies; contribute to risk mitigation, scenario forecasting, and strategic recommendations for market access or lifecycle management

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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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.

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.

The role can be fully home based or office based.

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.

Skills & Experience required for the role:

University Degree in a Scientific or Technical Discipline
Strong understanding of EU 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.
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.
Exceptional written and verbal communication skills, capable of explaining regulatory concepts to non‑experts.
Skilled in preparing high‑quality presentations, summaries, and strategic updates.
Fluent in English, written and spoken