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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
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
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
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO
Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area.
Primary Responsibilities:
In this role, you will lead regulato
Principal Specialist, Regulatory Affairs - Permanent - Denver, CO
Proclinical is seeking a Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area.
Primary Responsibilities:
In this role, you will lead regulatory strategies fo
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow. Based on intelligence gained from over 10 million scans in more than 2,000 hosp
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow. Based on intelligence gained from over 10 million scans in more than 2,000 hosp
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent ma
Job Source: Eurofins Agro NL
Executive Director, Regulatory Affairs
Denver, CO, 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
Genomics
Therapeutics
Clinical Care
Patient Management
Healthcare
Life Sciences
Personalized Medicine
Medicine
Chemical Products
Specialties
Biologics
Human therapeutics
and Development of novel products
Business Classifications
B2C
Mobile
About the Role
The Company is seeking an Executive Director of Regulatory Affairs to join their team. This pivotal role involves leading and directing regulatory affairs activities within an assigned therapeutic area, ensuring compliance with global and regional laws and regulations. The successful candidate will provide strategic leadership to the regulatory affairs team, oversee the development of regulatory strategies, and engage in effective interactions with regulatory agencies. Responsibilities also include providing regulatory expertise to commercialization teams, contributing to the development of global and regional product labels, and influencing the regulatory legislative environment in line with the company's policy priorities. The role requires a strong leader with the ability to manage and mentor staff, champion change, and foster a culture of continuous improvement.Candidates for the Executive Director of Regulatory Affairs position at the company should have a Doctorate, Master's, or Bachelor's degree in a relevant field, along with a significant amount of experience in regulatory affairs and at least 6 years of managerial experience. The ideal candidate will have a proven track record of leading teams, excellent communication skills, and the ability to understand and communicate scientific and clinical information effectively. They should be adept at setting organizational direction, anticipating strategic issues, and resolving conflicts to achieve positive outcomes. The role demands a leader who can inspire and empower their team, accelerate progress in line with patient needs, and integrate the company's resources to drive results.
Hiring Manager Title
Senior Vice President Global Regulatory Affairs and Strategy