Director, Regulatory Affairs

3 weeks ago

Boston, United States Imbria Pharmaceuticals Full time

Company Overview

Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit www.imbria.com.

Position Overview

The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. The position is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities. This position would be held accountable for establishing strategic plans, policies, and procedures to ensure the company fulfills its obligations and commitment. Note: This position requires the incumbent to reside in the Boston area.

Responsibilities

  • Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members
  • Communicate regulatory strategies and plans to ensure alignment with the overall project plan and business strategy
  • Direct and lead regulatory submissions
  • Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings
  • Lead the management and oversight of regulatory activities relating to clinical trials including but not limited to clinical trial applications.
  • Assure compliance with regulatory reporting requirements
  • Perform other duties as required

Qualifications

  • Bachelors degree Life/Health Sciences; Masters degree a plus
  • Minimum of 10 years of experience in pharmaceutical / biotech
  • Minimum 6 years in a management role within Regulatory
  • Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activities
  • Regulatory CMC experience a plus
  • Excellent knowledge of regulatory, GxP, compliance, laws, and regulations for pharmaceutical products
  • Experience developing products, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc.
  • Proven ability to establish strategy and to translate it into an effective, long term action plan
  • Thorough understanding of the regulatory process from development through commercialization
  • Strong project management skills
  • Established track record with evidence of excellent project management, problem solving, collaborative, leadership, and communication skills
  • Strong written and oral communication skills
  • Able to grasp complex technical issues and make sound decisions based on data and information from various sources

This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria

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