RemoteLeaf Logo
Log in Sign up

Senior Director, Regulatory Affairs

3 weeks, 3 days 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

Similar Roles

Binance

Binance Accelerator Program - Compliance Analyst

Binance 5K-10K Capital Markets

Binance’s Accelerator Program is seeking an early-career Compliance Analyst in Europe to support KYC and AML compliance operations within its global blockchain and crypto ecosystem.

Europe Internship Entry Level Compliance Manager
Blockchain
1 hour, 33 minutes ago
Mindrift.ai: Be the “I” in AI

Regulatory Compliance Manager (CRCM) - Freelance AI Trainer

Mindrift.ai: Be the “I” in AI Internet Software & Services

Mindrift is seeking project-based U.S. banking compliance specialists to evaluate and create regulatory testing scenarios for AI systems used by leading tech companies.

United States Part-time Senior Compliance Manager Training Manager
Up to $125k
1 hour, 44 minutes ago
RecargaPay

Compliance Coordinator

RecargaPay 251-1K Capital Markets

RecargaPay is hiring a Compliance Coordinator to support regulatory and advisory compliance work across products, operations, and strategic initiatives in Brazil’s fast-changing financial market.

Brazil Full-time Senior Compliance Manager
2 hours, 21 minutes ago
bridgebiowp

Sr. Director, Regulatory Affairs - CMC

bridgebiowp 251-1K Pharmaceuticals

BridgeBio is seeking a Regulatory CMC leader to drive global regulatory strategy and submissions for biotechnology and pharmaceutical development and post-approval programs.

United States Full-time Lead Compliance Manager
$285k-$320k
4 hours, 9 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers