Job Title:
Regulatory Consultant (CMC / EU Market Experience)
📍 Location: IND – Remote
🆔 Job ID: 25101141
📅 Updated: August 20, 2025
🏢 Company: Syneos Health
🌐 Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to advancing customer success. With more than 29,000 employees across 110 countries, we partner with emerging and global biopharma companies to accelerate therapy delivery through clinical, medical affairs, and commercial expertise.
“Work Here Matters Everywhere” — At Syneos Health, we challenge the status quo and impact global health outcomes.
📝 Position Summary
As a Regulatory Consultant (CMC), you will provide expert regulatory and technical support for post-approval CMC submissions including variations, renewals, annual reports, legal entity name changes, and other lifecycle maintenance activities. This role emphasizes EU market experience and regulatory strategy across global regions including GCC and MEA.
🎯 Key Responsibilities
📁 Regulatory Documentation & Submissions
Author and review Module 3 (CMC) documentation for:
Post-approval variations
Renewals
Annual reports
Legal entity name change (LENC) variations
Ensure submission compliance with EU and global regulatory guidelines.
Prepare and contribute to:
INDs, NDAs, MAAs, PMAs
Briefing packages for agency meetings
Product registration and lifecycle maintenance applications
🔍 Regulatory Strategy & Analysis
Assess regulatory impact of changes initiated via change control.
Develop and implement effective submission strategies.
Conduct regulatory gap analyses and research existing product data.
Participate in product development planning from a regulatory perspective.
🤝 Client and Team Collaboration
Act as regulatory lead on multidisciplinary teams (clinical, technical, QA).
Support client discussions, proposal development, and project delivery updates.
Participate in internal and external audits.
Mentor team members and assist in solving regulatory project challenges.
🔧 Process Management & Compliance
Ensure regulatory activities adhere to:
Syneos Health SOPs
Global regulatory requirements
Project budgets and timelines
Prepare training content and share best practices across the team.
Assist in SOP development and updates as required.
Maintain personal training records and complete all required training activities.
🧾 Required Qualifications
🎓 Education
MS, M.Pharm, or PhD (Science-related field preferred)
Equivalent scientific/regulatory experience accepted
📅 Experience
5+ years of total professional experience
4+ years in Regulatory Affairs, focusing on CMC submissions
Proven experience with:
EU regulatory submissions (mandatory)
GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE)
MEA regions (preferred)
💼 Technical Expertise
Strong knowledge of:
CTD structure
eCTD submissions
Post-approval CMC submissions
Tools:
Veeva RIMS, TrackWise, and other RIMS systems
Microsoft Office Suite
🧠 Skills & Competencies
Excellent written and verbal communication skills
Strong interpersonal and client service orientation
High attention to detail and analytical ability
Able to manage multiple projects with varied instructions
Proactive, adaptive, and capable of working independently and collaboratively
Fluent in spoken and written English
🏆 Why Join Syneos Health
Career development opportunities & technical training
Inclusive Total Self Culture promoting authenticity and diversity
Opportunities to work on global, impactful projects
Work-from-home flexibility (Remote role)
📌 Additional Information
This role’s tasks and responsibilities are not exhaustive and may evolve.
Equivalent qualifications or experience may be considered.
Compliance with global employment and accessibility standards, including Americans with Disabilities Act, is ensured.
This is not an employment contract and may be modified at the company's discretion.
🚀 How to Apply
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