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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, 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: AlconImbria 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 PharmaceuticalsImbria Pharmaceuticals
Fort Worth, TX, United States
Position Overview We are seeking a Director Supply Chain who is experienced, highly energetic, and committed to developing and executing the company’s supply strategy across all clinical and pre-clinical programs. This individual will be responsible for designing, building and shaping the supply chain capability for future growth into multiple clin
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: TCWGlobalAerospace Industries Association of America
Arlington, TX, United States
Do you have a passion for aerospace? Want to work for an association that connects some of the largest companies in the field? A role at AIA might be a great fit for you. Take a look at our open positions to see if one matches your skill set. Open Positions To learn more about a role, click on the job title to see the details. ____________________
Job Source: Aerospace Industries Association of AmericaTen Bridge Communications
Fort Worth, TX, 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 CommunicationsCharles Schwab
Westlake
**Your opportunity** **Director, Corporate Affairs Operations** Schwab’s Corporate Affairs team creates value by engaging stakeholders in Schwab’s story, building trust and protecting and strengthening the firm’s reputation. We are shapers and protectors of Schwab’s communications, culture and reputation, building connections with stakeholders insi
Job Source: Charles SchwabFort 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 - Boston Remote jobs in Fort Worth, TX, United States
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