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Parabilis Medicines logo
Parabilis Medicines

Advancing ultra-tunable Helicon peptide therapeutics to achieve extraordinary outcomes for people affected by cancer.

Associate Director, Regulatory Operations

ComplianceComplianceOtherRemoteSeniorTeam 51-200Since 2016H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

158 days ago

Salary

$165K - $200K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglish

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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