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Senior Director, Regulatory Affairs

6 days, 12 hours ago
United States
Full-time
Lead
Compliance Manager
Operations
Apply Now
Contineum Therapeuctics

Contineum Therapeuctics

Contineum Therapeuctics is pioneering innovative therapies that target conditions at the intersection of neuroscience, inflammation, and immunology, focusing on developing treatments with clinically validated biological targets to improve options for p...

Pharmaceuticals
Founded 2017
View All Jobs

Description

  • Represent regulatory affairs on study and program teams throughout study conduct and product development.
  • Prepare and review global regulatory documents, including New INDs/CTAs, DSURs, IND amendments, health authority briefing materials, iPSP/PIP, and NDA/MAA submissions.
  • Oversee the regulatory submissions vendor to ensure technical accuracy, compliance, completeness, and timely agency filings.
  • Lead global regulatory submission development and manage responses to health authority questions and information requests.
  • Manage and mentor direct reports to support department and corporate goals.
  • Support company compliance initiatives, including SOP development and documentation processes.
  • Review clinical documents such as protocols, informed consent forms, investigator’s brochures, site documentation, and regulatory forms for compliance.
  • Maintain current knowledge of U.S. and ex-U.S. regulations affecting company products and processes.

Requirements

  • Bachelor’s degree required; advanced degree preferred.
  • 12+ years of experience in pharmaceutical or biotech, including at least 10 years in regulatory affairs with clinical regulatory affairs experience.
  • Experience managing and mentoring direct reports.
  • Experience creating systems and processes that support efficient, high-quality regulatory submissions.
  • Ability to translate regulatory requirements into practical, achievable plans.
  • Ability to build strong working relationships across diverse teams and disciplines.
  • Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment.
  • Strong organizational and multitasking skills.
  • Excellent communication and interpersonal skills.
  • Ability to interact with regulatory authorities and adhere to relevant procedures and regulations.

Benefits

  • Competitive total compensation package with a salary range of $240,000 to $265,000 annually for candidates based in San Diego, CA.
  • 90% employer-covered benefits.
  • Flexible PTO.
  • Generous holiday schedule, including a week off in August and time off around the winter holidays.
  • Opportunity for annual bonuses.
  • Stock options.
  • Employee Stock Purchase Program.
  • 401(k) with employer match.
  • Comprehensive wellness program with medical, dental, vision, and LTD coverage.
  • Well-stocked kitchen with snacks and beverages.

Interested in this position?

Apply directly on the company website

Apply Now

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