Senior Regulatory Affairs Associate – EU Regulatory Intelligence

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Romania

Posted

90 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Senior Regulatory Affairs Associate – EU Regulatory Intelligence

Parexel

• 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. • 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. • 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. • 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.

Job Requirements

  • 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.

Benefits

  • Remote work options
  • Professional development opportunities

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