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Imbria Pharmaceuticals
Columbus, OH, United States
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
Job Source: Imbria PharmaceuticalsThe Mullings Group
Columbus, OH, United States
Director of Global Regulatory Affairs Class III : Structural Heart : PMA Santa Clara : Hybrid Remote Full Time : Direct Hire Our client is developing the first transcatheter septal occluder with a metal-free frame, as the new standard of care for atrial septal defects. Delivered through a 12F sheath and over a standard guidewire, the low-profile de
Job Source: The Mullings GroupImbria Pharmaceuticals
Columbus, OH, United States
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
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
Columbus, OH, United States
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
Job Source: Imbria PharmaceuticalsProfessional Diversity Network
Columbus, OH, United States
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Job Source: Professional Diversity NetworkAmgen
New Albany
**HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology comp
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Columbus
**Job Description** We are seeking a Growth and Improvement minded Regional Medical Scientific Director (AKA Medical Science Liaison / MSL) | in Inflammatory Bowel Disease Immunology that can help drive our Strategic Operating Priorities. **Summary, Focus and Purpose** The Regional Medical Scientific Director (Medical Science Liaison) is a credenti
Job Source: MerckTen Bridge Communications
Columbus, OH, United States
Are you an experienced communications professional focused on growing your expertise in the biotech industry? We’re a thriving strategic communication, digital and creative agency based in Boston that works with trailblazers in the biotech industry. We’re looking for a motivated and enthusiastic leader steeped in this sector - or one with a strong
Job Source: Ten Bridge CommunicationsColumbus, OH, United States
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.
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
We offer a competitive total compensation package and invite you to consider a career with Imbria!
Email Alert for Director, Regulatory Affairs - Boston Remote jobs in Columbus, OH, United States
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