Job Title:
Senior Regulatory Associate (Module 1)
Location: Remote, India
Job ID: 25101578
Updated: Yesterday
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into actionable outcomes to meet modern healthcare challenges.
Why Syneos Health:
Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic area training programs
Peer recognition and total rewards
Inclusive Total Self culture encouraging authenticity and belonging
Vision: Simplifying processes and accelerating delivery of therapies while keeping patients and customers at the center.
Job Summary:
The Senior Regulatory Associate (Module 1) supports preparation and management of regulatory submission documents, focusing on Module 1 (administrative and regional information). The role involves regulatory document preparation, tracking, research, and communication to ensure compliance with Health Authority regulations.
Experience Required: Minimum 4 years in regulatory, quality, or document management support roles.
Key Responsibilities:
1. Regulatory Document Preparation
Assist with preparation of Module 1 documents and collection of country-specific administrative forms
Prepare regulatory submission documents, including:
Investigational New Drug applications (INDs)
New Drug Applications (NDAs) / Marketing Authorization Applications (MAAs)
Drug Master Files (DMFs), variations, renewals
Marketing Authorization Transfers (MATs) and other lifecycle maintenance activities
Prepare responses to Health Authority queries and track HA commitments
2. Documentation & Compliance
Maintain and update regulatory trackers, submission timelines, and status reports
Ensure proper archiving of submission documentation
Comply with internal SOPs and regulatory guidelines
3. Regulatory Research & Support
Conduct regulatory research to identify precedents and support orphan drug designation requests
Assist clients or internal stakeholders with regulatory-related information
Gather data, search files, and prepare detailed reports or routine correspondence
Qualifications & Skills:
Educational: Master’s in Pharmaceutical Sciences
Experience: Around 4 years in regulatory, quality, or document management support
Technical Skills: Advanced Microsoft Office applications (Word, Excel, PowerPoint)
Additional Skills:
Excellent interpersonal and communication skills
Good time and project management skills
Additional Information:
Job responsibilities are not exhaustive; additional tasks may be assigned as needed
Equivalent experience, skills, and education may be considered
This job description does not create an employment contract
Compliance with local and international regulations, including ADA provisions
About the Role:
Supports regulatory submissions and lifecycle maintenance activities for global clients
Ensures accuracy, compliance, and timely delivery of regulatory documents
Plays a critical role in maintaining Health Authority commitments and regulatory intelligence
Learn More: www.syneoshealth.com
Application:
Apply now or join the Talent Network to stay connected with future opportunities
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