PHARMAFull-time
Senior Regulatory Affairs Associate- Clinical Trial Application
By Admin · Regulatory Affairs
REMOTE (IN)REMOTEPOSTED: 9/16/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE OVERVIEW
Lead end-to-end Clinical Trial Application submissions across EU CTR and Rest of World regions, coordinating global regulatory projects, timelines, documentation, stakeholders and risk management to support compliant clinical-trial submissions.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead end-to-end Clinical Trial Application project management across multiple studies and countries
- •Plan, track and deliver submissions according to regulatory timelines
- •Manage risks, dependencies and complexities across global regulatory environments
- •Apply EU CTR and Rest of World CTA requirements
- •Manage core clinical and regulatory documentation
- •Collaborate with cross-functional global teams and maintain stakeholder relationships
- •Monitor KPIs for timelines and deliverable quality
- •Identify risks and lead quality investigations when required
Reporting Hierarchy: Reports within Parexel Consulting and works with global cross-functional and client teams in a matrix environment
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Sciences, Pharmacy or related field
- Minimum 5+ years of industry experience in pharmaceutical, CRO or similar environment
- Experience with Clinical Trial Application submissions across EU CTR and ROW
- Strong project-management experience in a global or matrix environment
- Familiarity with clinical trials and regulatory processes
- Strong communication, problem-solving and stakeholder-management skills
PREFERRED QUALIFICATIONS
- •Experience across multiple countries and regulatory environments
- •Experience managing complex global regulatory submissions
- •Strong conflict-resolution and relationship-building skills
- •Adaptability, resilience and teamwork
REQUIRED VERIFIED SKILLS
Clinical Trial Applications
EU CTR
ROW submissions
Regulatory Affairs
Global regulatory submissions
Project management
Clinical trials
Regulatory documentation
Risk management
Issue management
KPI tracking
Stakeholder engagement
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Remote-work flexibility, mentorship, professional development and exposure to diverse clients, product types and therapeutic areas
The supplied job posting does not disclose salary or bonus/equity figures, so no compensation amount has been inferred.
ORGANIZATION CONTEXT & CULTURE
Parexel is a global clinical research and biopharmaceutical services organization that provides clinical development, regulatory and consulting support to life-sciences companies.
TEAM SIZE: 10,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
Culture: The supplied posting emphasizes collaboration, innovation, continuous learning, mentorship, client exposure and a supportive remote working environment.
EXPECTED CAREER ROADMAP
Potential progression may include lead-level regulatory submission responsibilities, broader global regulatory project management, regulatory consulting leadership, program management or specialized clinical-trial regulatory roles, depending on experience and internal opportunities.
APPLICATION ADVISORY
Highlight 5+ years of pharmaceutical, CRO or regulatory experience; clearly demonstrate EU CTR and ROW CTA submission experience; quantify the number or complexity of global submissions managed; emphasize project management, regulatory documentation, risk management and cross-functional stakeholder coordination.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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