Job Title:
Regulatory Associate
Location: IND-Gurugram
Job ID: 25101793
Updated: September 18, 2025
Company Overview – Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. The company emphasizes patient-centric clinical development and continuous process optimization.
Key Highlights:
Operates in 110 countries with 29,000 employees.
Partnered with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies, 73,000 sites, and 675,000+ trial patients in the last 5 years.
Supports career development, technical training, and peer recognition.
Promotes a diverse, inclusive, and authentic workplace through the Total Self culture.
Role Summary
The Regulatory Associate supports regulatory agency submissions, regulatory research, and product development under supervision. Responsibilities include preparing submission documents for various lifecycle regulatory activities.
Key Responsibilities
Assist in preparation of product development documents, including gap analyses and clinical development plans.
Support preparation of regulatory submission documents, including:
Investigational New Drug applications (INDs)
New Drug Applications / Marketing Authorizations (NDAs/MAAs)
Drug Master Files (DMFs)
Variations, renewals, and marketing authorization transfers (MATs)
Conduct regulatory research to identify precedents and support orphan drug designation requests.
Perform quality checks on documents.
Assist with submissions of other regulatory documents as needed.
Gather, compile, analyze, and report information for regulatory purposes.
Prepare detailed reports and compose routine correspondence.
Candidate Profile / Skills
Education: BS in science/healthcare or equivalent experience.
Excellent interpersonal and communication skills.
Proficiency in Microsoft Office Applications (Word, Excel, PowerPoint).
Strong analytical, organizational, and attention-to-detail skills.
Good time and project management skills preferred.
Ability to work independently and in a team, following detailed instructions.
Ability to handle multiple projects concurrently, with varying instructions.
Fluent in English (spoken, written, and reading).
Additional Information
Tasks listed are not exhaustive; company may assign additional duties.
Equivalent skills or experience may be considered in lieu of formal qualifications.
Nothing in this description constitutes an employment contract.
Syneos Health is committed to ADA compliance and providing reasonable accommodations.
How to Apply
Apply directly via Syneos Health website.
Not ready to apply? Join the Talent Network to stay connected for future opportunities.
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