Regulatory Affiliate
About the Role
Role & Responsibilities – Regulatory Affiliate
• Review, compile, and submit regulatory dossiers to Health Authorities
• Liaise and negotiate with Health Authorities to support approvals and lifecycle management
• Collaborate with Medical, Marketing, Market Access, and Local Regulatory teams
• Assess and manage the impact of regulatory changes on marketed products
• Ensure compliance with local regulatory requirements and timelines
Qualification
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline
Experience
• 2–6 years of hands-on experience in Regulatory Affairs
• Experience in Regulatory Intelligence or Regulatory Affiliate operations preferred
Skills
• Strong understanding of global and local regulatory guidelines
• Experience with regulatory submissions and health authority interactions
• Excellent communication and stakeholder management skills
• Ability to interpret regulatory changes and assess business impact
About the Company
• Parexel is a leading global provider of biopharmaceutical services and regulatory consulting, Known for regulatory excellence, patient-centric innovation, and global reach
AI Career Power Suite
Resume Analyst
Unlock refined AI insights.
Interested?
Frequently Asked Questions
Everything you need to know about the process