Regulatory Consultant
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Arizona • Maine • United States
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Tech Stack
About the role
- Responsible for the development of regulatory submissions and post-marketing regulatory support for clients
- Includes authorship of portions of regulatory submissions, regulatory writing, and regulatory research
- Ensures compliance with relevant guidelines and standards
- Provides advice and assistance to clients and other associates in areas of expertise
- May manage smaller client projects
- Supports new business development in area of expertise
Requirements
- Experience with Veeva Vault RIM is required
- Lifecycle maintenance and compliance submissions
- Experience with Module 1 for US Submissions is required
- Familiarity with eCTD
- Must be located in US with no sponsorship needs
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory writingregulatory researchcompliance submissionslifecycle maintenanceModule 1 for US SubmissionseCTD
Soft Skills
client managementadvice and assistancebusiness development