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Alcon
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of ou
Job Source: AlconISTITUTO MARANGONI
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of ou
Job Source: ISTITUTO MARANGONIAlcon
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, youll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our
Job Source: AlconThe Mullings Group
Fort Worth, TX, 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
Fort Worth, TX, 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 cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsRandstad US
Fort Worth
regulatory affairs specialist ii. + fort worth , texas (remote) + posted june 10, 2024 **job details** summary + $50 - $53.57 per hour + contract + high school + category life, physical, and social science occupations + reference48290 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you
Job Source: Randstad USTCWGlobal
Fort Worth
Job Description Job Description Regulatory Affairs Specialist (R&D/QA) Fort Worth, TX 76104 (*Local candidates- 3 days on site/2 days remote) $43-$45hr (Weekly pay + Benefits) 1yr contract (Excellent potential for extension or permanent) Full-time- M-F 8am-5pm Our client is a global team of innovators, leaders, creators, builders, and problem s
Job Source: TCWGlobalPlanned Parenthood of Metropolitan Washington, DC, Inc.
Arlington, TX, United States
Description: Job Title: Director of Government Affairs and Policy Department/Location: Public Affairs FLSA Status: Full time, Exempt Supervisory Role: Yes Reports to: Assistant Vice President of Policy and Organizing Job Summary: The Public Affairs Department's Director of Government Affairs and Policy will play a crucial role in advancing the legi
Job Source: Planned Parenthood of Metropolitan Washington, DC, Inc.Fort Worth, TX, 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 cell’s 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
Bachelor’s degree Life/Health Sciences; Master’s 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 - Connecticut Remote jobs in Fort Worth, TX, United States
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