Senior Regulatory Affairs Associate tracking global regulations and leading impact assessments. Supporting Parexel’s clinical research and life sciences consulting solutions through regulatory intelligence.
About the role
- Senior Regulatory Affairs Associate managing EU CTA strategy, submissions, and compliance for Parexel’s global clinical research services. Coordinating health authorities, CROs, and cross-functional teams.
Responsibilities
- Provide operational and regulatory support for CTA submissions and maintenance activities
- Prepare and coordinate global CTA and amendment documentation
- Manage dossier development and ensure quality and completeness
- Manage or facilitate submissions to health authorities or via local personnel
- Serve as the primary point of contact for regulatory interactions
- Liaise with and oversee CROs for submissions and query management
- Ensure timely and accurate responses to regulatory inquiries
- Implement global CTA strategy
- Ensure quality and compliance with country-specific requirements
- Maintain tracking and archiving of regulatory submissions
- Communicate EU regulatory requirements and updates to cross-functional teams
- Contribute to process improvements in regulatory submission management
- Collaborate with cross-functional teams and follow industry-standard processes from planning through closeout
Requirements
- Bachelor's degree in Life Science or equivalent experience
- 6+ years in pharmaceutical industry with 5+ years in Regulatory Affairs
- Strong knowledge of EU drug development, CTR, and CTIS regulatory frameworks
- Demonstrated experience with CTA submission processes and regulatory compliance
- Proven leadership in EU CTA documentation and submissions
- Strong knowledge of EU drug development, CTR, and CTIS workflows across multiple jurisdictions
- Project management and leadership skills
- Ability to coordinate cross-functional teams and manage vendor relationships
- Excellent communication, organization, collaboration, and problem-solving skills
- Experience in clinical research, healthcare, or a regulated environment
- Strong attention to detail and quality mindset
- Familiarity with regulatory submission tracking systems and electronic document management tools
- Knowledge of additional regulatory pathways beyond EU requirements is preferred
- Ability to work ET hours; eastern or central time zone of Canada highly preferred
Benefits
- Competitive salaries based on position, level, skills, education, training, experience, professional achievements, and location
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs
- Flexibility
- Growth opportunities
- Space to do your best work
- Continuous learning opportunities
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