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Advancing ultra-tunable Helicon peptide therapeutics to achieve extraordinary outcomes for people affected by cancer.
Associate Director, Regulatory Operations
Location
Massachusetts
Posted
158 days ago
Salary
$165K - $200K / year
Seniority
Senior
Job Description
Associate Director, Regulatory Operations
Parabilis Medicines
• 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.
Job 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
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