Associate Director, Regulatory Operations
Parabilis Medicines
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $165,000 - $200,000 per year
Job Level
About the role
- Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs.
- Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments.
- Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates.
- Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations.
- Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development.
- Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments.
- Oversee relationships with external vendors and contractors for systems and technology.
Requirements
- Bachelor’s degree or equivalent experience
- 8-10+ years industry experience
- Expertise in electronic submission standards (eCTD) and regulatory information management (RIM) systems.
- Strong leadership, communication, and problem-solving skills.
- Ability to manage complex projects, priorities, and budgets.
- Deep knowledge of applicable FDA, EMA, and other relevant health authority guidelines
- Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus
Benefits
- an annual target bonus
- equity
- a comprehensive suite of competitive benefits designed to support our employees’ overall well-being
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eCTDregulatory information management (RIM)project managementcompliance managementcontinuous improvementstandard operating proceduresregulatory document templatesAI tools
Soft skills
leadershipcommunicationproblem-solvingproject managementprioritization
Certifications
Bachelor’s degree