PHARMAFull-time
Senior Regulatory Affairs Associate
By Admin · Regulatory Affairs
BANGALORE (IN)REMOTEPOSTED: 9/10/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE OVERVIEW
Lead end-to-end Clinical Trial Application submission activities across EU CTR and Rest of World regions, ensuring compliant, high-quality and timely regulatory delivery.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead end-to-end CTA project management across multiple studies and countries
- •Plan, track and deliver regulatory submissions against timelines and requirements
- •Manage risks, dependencies and complexities across global regulatory environments
- •Apply EU CTR and Rest of World CTA requirements
- •Manage clinical and regulatory documentation
- •Collaborate with global cross-functional teams and maintain stakeholder relationships
- •Monitor submission KPIs and deliverable quality
- •Identify risks and lead quality investigations when required
Reporting Hierarchy: Works within Parexel's clinical development and regulatory services organization; Leads CTA activities across studies and countries; Collaborates with global cross-functional teams and stakeholders and provides project-level regulatory coordination
* 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 pharmaceutical, CRO or related industry experience
- Experience with Clinical Trial Application submissions
- Experience with EU CTR and Rest of World submissions
- Strong project management experience in a global or matrix environment
- Familiarity with clinical trials and regulatory processes
PREFERRED QUALIFICATIONS
- •Experience leading multiple-country CTA submissions
- •Strong knowledge of EU CTR
- •Global regulatory submission experience
- •Experience with risk and issue management
- •Experience working with cross-functional global stakeholders
REQUIRED VERIFIED SKILLS
Clinical Trial Applications
EU CTR
ROW submissions
regulatory affairs
regulatory submissions
project management
risk management
issue management
stakeholder engagement
clinical trial documentation
KPI monitoring
quality investigations
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development and global project exposure; collaborative cross-functional environment; opportunities to contribute to clinical development and regulatory submissions
The posting does not disclose a salary range or bonus/equity amount; compensation should therefore be treated as undisclosed.
ORGANIZATION CONTEXT & CULTURE
Parexel is a global clinical research and development services organization supporting pharmaceutical and biotechnology companies across clinical trials, regulatory, consulting and market access.
TEAM SIZE: 20,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
Culture: Parexel emphasizes patient impact, empathy, collaboration, regulatory excellence and a shared commitment to improving global health.
EXPECTED CAREER ROADMAP
Potential progression into Regulatory Affairs Manager, Clinical Trial Submission Lead, Global Regulatory Project Lead or broader regulatory operations leadership roles.
APPLICATION ADVISORY
Emphasize 5+ years of regulatory or CRO/pharmaceutical experience; clearly demonstrate EU CTR and ROW CTA submission experience; highlight end-to-end project management across countries; quantify submission delivery, timeline and quality achievements; showcase risk management and global stakeholder coordination.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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