Job Title: Regulatory Associate
Location: Gurugram, India
Job ID: 25101793
Company: Syneos Health®
Status: This job posting is no longer active (for talent pipeline consideration)
Updated: Yesterday
🧭 About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success by uniting clinical, medical affairs, and commercial insights to address modern market realities.
With a workforce of 29,000 employees across 110 countries, Syneos Health operates through both Functional Service Provider (FSP) and Full-Service models, enabling customers to bring therapies to patients faster and more effectively.
💡 Work Here Matters Everywhere
🌟 Why Join Syneos Health
Career growth & development opportunities
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive Total Self Culture that encourages authenticity and diversity
🧩 Job Summary
Under supervision, the Regulatory Associate supports regulatory agency submissions, regulatory research, and product development activities.
Key responsibilities include preparing submission documents to support:
Investigational New Drug Applications (INDs)
New Drug Applications (NDAs) or Marketing Authorisation Applications (MAAs)
Drug Master Files (DMFs)
Variations, Renewals, Marketing Authorisation Transfers (MATs)
Other lifecycle maintenance activities
📋 Key Responsibilities
🔹 Regulatory Document Preparation
Assist with preparation of product development documents including gap analyses and clinical development plans
Support preparation of regulatory submission documents such as INDs, NDAs/MAAs, DMFs, MATs, renewals, and variations
Ensure documents comply with current regulations and guidelines
🔹 Regulatory Research & Support
Conduct regulatory research to identify precedents and support orphan drug designation requests
Assist with regulatory submissions and document quality checks
Support other regulatory research and administrative tasks as needed
🔹 Reporting & Communication
Gather, compile, analyze, and report information
Search files, records, and perform outreach to collect required data
Prepare detailed reports and compose routine correspondence
Provide general information and support to clients, customers, and internal stakeholders
🎓 Qualifications
Education
Bachelor’s degree in Science/Healthcare field (or equivalent combination of education and experience)
Skills & Competencies
Excellent interpersonal and communication skills
Advanced Microsoft Office skills (Word, Excel, PowerPoint, Outlook)
Strong analytical ability and attention to detail
Effective time management and project coordination skills
Ability to work independently and as part of a cross-functional team
Capable of managing multiple projects concurrently
Fluent in English (spoken, written, and reading)
💡 Additional Information
This posting is for a potential upcoming opportunity (Talent Pipeline)
Equivalent education/experience/skills may be considered
The company may assign other related duties as needed
Committed to Equal Opportunity Employment and ADA compliance
🌍 About Syneos Health (Quick Facts)
Partnered on 94% of FDA Novel Drug Approvals in the last 5 years
Supported 95% of EMA Authorized Products
Managed 200+ studies across 73,000 sites and 675,000+ trial patients
Website: www.syneoshealth.com
✅ Job Category: Regulatory Affairs / Clinical Operations
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