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Imbria Pharmaceuticals
Philadelphia, PA, 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 PharmaceuticalsFairway Consulting Group
Philadelphia, PA, United States
Our client is a clinical-stage biopharmaceutical company focused on developing medicines for life threatening diseases. They have retained us to assist them in their search for a Director of Regulatory Affairs. Major tasks and responsibilities include: Interacts with key personnel in regulatory agencies to ensure the review and approval of develop
Job Source: Fairway Consulting GroupFairway Consulting Group
Philadelphia, PA, United States
Our client is a clinical-stage biopharmaceutical company focused on developing medicines for life threatening diseases. They have retained us to assist them in their search for a Director of Regulatory Affairs. Major tasks and responsibilities include: Interacts with key personnel in regulatory agencies to ensure the review and approval of devel
Job Source: Fairway Consulting GroupExelixis
King of Prussia, PA, United States
SUMMARY/JOB PURPOSE: Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidances and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis' FDA (Food and D
Job Source: ExelixisConfidential
Philadelphia, PA, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Genom
Job Source: ConfidentialMeet Recruitment Limited
Philadelphia, PA, United States
Seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects of their rare disease development programs, working closely with other departments. Will be onsite in Greater Philadelphia Resp
Job Source: Meet Recruitment LimitedExelixis
King of Prussia, PA, United States
SUMMARY/JOB PURPOSE: Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company-wide initiatives around end-to-end labeling and provides dedicated support on Regulatory-related activities and deli
Job Source: ExelixisConfidential
Philadelphia, PA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialPhiladelphia, PA, 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!
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Email Alert for Director, Regulatory Affairs - Connecticut Remote jobs in Philadelphia, PA, United States
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