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Regulatory Affairs Consultant – Regional Submission Coordinator
ParexelRegulatory Affairs Consultant managing regulatory submissions in Brazil for Parexel. Coordinating activities and ensuring compliance with local regulatory requirements.
About the role
Key responsibilities & impact- Coordinate the preparation, compilation, and submission of new drug applications and Lifecycle Manage (LCM) activities
- Organize the submission team meetings (“Kickoff Meeting”)
- Facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Responsible (LRR) or Regulatory Partner Representative (RPR)
- Prepare the Submission Content Plan (SCP) based on country-specific regulatory requirements
- Support the M1 documents preparation
- Ensure appropriate archiving of labeling documentation
- Track the dispatched documentation for each country
- Proactively identify potential project issues, risks, and roadblocks that may impact submission timelines
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Pharmacy, or related field
- 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Strong understanding of regional regulatory submission processes
- Experience with different international regulatory submission routes preferred (e.g. ACCESS, reliance pathways)
- Excellent project management and organizational skills
- Strong communication and stakeholder management abilities
- Proficiency in regulatory tracking systems and Microsoft Office Suite
- Ability to work collaboratively across global and regional teams
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submission processesproject managementregulatory tracking systemsM1 documents preparationSubmission Content Plan (SCP)Lifecycle Management (LCM)labeling documentation archivinginternational regulatory submission routesACCESSreliance pathways
Soft Skills
organizational skillscommunication abilitiesstakeholder managementcollaborative workproblem identificationrisk management
Certifications
Bachelor's degree in Life SciencesBachelor's degree in Pharmacy