Senior Regulatory Strategy Associate

Parexel

. Develop and recommend regulatory pathways for assigned products, studies, or markets .

Posted 10/16/2026full-timeRemote • CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory strategy and compliance, with a strong focus on FDA regulations and clinical trial processes. Proven ability to collaborate across teams and effectively communicate with stakeholders while maintaining a patient-focused mindset.

Highest-signal resume keywords

Regulatory StrategyFDA Regulation ExpertiseRegulatory Affairs ExperienceClinical Development KnowledgeSubmission Tracking Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationRegulatory Pathways DevelopmentRegulatory Risk IdentificationICH-GCP KnowledgeClinical Trial ProcessesRegulatory ComplianceRegulatory Submission PreparationStrategic ThinkingProblem-SolvingAttention to Detail

Soft Skills

CollaborationClear CommunicationOrganizationPatient-Focused MindsetStrong Attention to Detail

Tools & Technologies

Regulatory DatabasesSubmission Tracking SystemsStandard Office ToolsRegulatory Submission SoftwareElectronic Tracking Systems

Industry Keywords

Regulatory AffairsClinical DevelopmentBiologic ProductsVaccine DevelopmentTherapeutic Areas

About the role

Key responsibilities & impact

Develop and recommend regulatory pathways for assigned products, studies, or markets
Support agency engagement planning and prepare materials for regulatory meetings
Identify key regulatory risks and opportunities to inform development strategy
Align regulatory approaches with development and commercialization objectives
Maintain current knowledge of regulatory requirements and industry guidance
Collaborate with cross-functional teams to ensure regulatory compliance and strategic alignment
Prepare regulatory documentation and submissions as needed
Track regulatory timelines and milestones to support program execution
Contribute to regulatory strategy from planning through implementation
Support regulatory strategy initiatives that advance new treatments for patients

Requirements

What you’ll need

Strengths in regulatory strategy, strategic thinking, and problem-solving
Experience working in regulatory affairs, clinical development, or a regulated environment
Ability to collaborate across teams and communicate clearly with internal and external stakeholders
Patient-focused mindset and strong attention to detail
Comfort working with regulatory databases, submission tracking systems, and standard office tools
Bachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience
4+ years of experience in regulatory affairs, clinical development, or a related field
Previous experience with vaccine and/or biologic products is required
FDA regulation expertise/knowledge is required
Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
Experience with regulatory databases or submission tracking systems
Strong communication, organization, and problem-solving skills
Advanced degree in regulatory affairs, pharmacy, or related field preferred
Experience in specific therapeutic areas or development phases preferred
Familiarity with regulatory submission software or electronic tracking systems preferred
Experience supporting FDA or international regulatory submissions preferred

Benefits

Comp & perks

Remote work arrangement
Flexibility
Growth opportunities
Continuous learning opportunities
Career path exploration and skill expansion across regulatory affairs and clinical development