Senior Regulatory Affairs Associate
Primary Location: Peru, Remote 求人ID R0000040927 Category Regulatory / Consulting
About this Role
Position Overview
We are seeking an experienced Sr Regulatory Affairs Associate in Peru to join our Clinical Trials team. In this pivotal role, you will serve as a local regulatory contact and global regulatory lead, managing complex clinical trial submissions across Latin America and supporting global regulatory strategy. You will combine technical expertise in regulatory submissions with strong communication and project management skills to drive successful clinical trial approvals.
Key Responsibilities
- Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
- Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
- Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
- Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
- Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
- Keep project management tools current, including budget tracking and quality issue (QI) tools
Required Experience
- Minimum 5+ years of professional experience in clinical trial regulatory affairs
- Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
- Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
- Proficiency with Veeva Vault or similar document management system
- Experience with regulatory requirements in APAC or EU regions (nIce to have)
Required Skills & Competencies
- Advanced written and spoken English proficiency
- Strong regulatory strategy expertise in Peru and LATAM countries
- Excellent verbal communication skills for presenting complex regulatory strategies to international clients
- Client-focused approach with ability to understand and anticipate sponsor needs
- Strong critical thinking and problem-solving abilities
- Exceptional interpersonal and intercultural communication skills
- Demonstrated ability to learn quickly and work with autonomy
- Results-oriented mindset with strong attention to detail
- Excellent teamwork, collaboration, and consulting skills
Why Join Parexel?
- Work with a global clinical research organization at the forefront of innovation
- Collaborate with international teams and sponsors on impactful clinical trials
- Develop your regulatory expertise in a supportive, growth-oriented environment
- Make a meaningful difference in bringing new therapies to patients
Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employee
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