We are looking for an experienced Associate Director Regulatory Affairs to lead and oversee regulatory compliance, product registration, and regulatory submissions across multiple markets. The role involves ensuring that all products meet FDA regulations, EMA guidelines, and other international regulatory standards while supporting strategic business objectives.
Key Responsibilities:
Lead the preparation and review of regulatory submissions for product approvals.
Ensure ongoing regulatory compliance with applicable laws, guidelines, and standards.
Develop regulatory strategies to support new product development and market expansion.
Collaborate with cross-functional teams on clinical trials and quality assurance requirements.
Maintain up-to-date knowledge of FDA regulations, EMA guidelines, and other global regulatory requirements.
Represent the company in communications with regulatory agencies.
Requirements:
Bachelors or advanced degree in Pharmacy, Life Sciences, or related field.
8+ years of experience in regulatory affairs, including leadership roles.
Strong knowledge of regulatory submissions, product labeling, and compliance processes.
Excellent leadership, communication, and project management skills.
Ability to work in a fast-paced, deadline-driven environment.
...offers a fully immersive, 10-week summer internship program. Our interns demonstrate curiosity, innovation, and a passion for advancing... ...a highly motivated and creatively curious Brand Concept Designer Intern to join our team. This role is ideal for a design student...
...Title: Healthcare Consultant I/ Case Coordinator Location: Work from Home. Training will be conducted remotely via Microsoft Teams. Candidates must reside in Miami-Dade County. Ability to multitask, prioritize, and effectively adapt to a fast-paced, changing...
...service we provide. Were looking for a Lawn Spraying Service Specialist to join our growing team. In this role, youll combine your... ...and join the Hoffer team! Hoffer Pest Solutions is proud to be an equal opportunity employer committed to workplace diversity....
...transforming cancer care by connecting every patient to cutting-edge clinical trialsregardless of location or financial barriers. Our AI-... ...to neighboring states as needed As a Clinical Trials Field Specialist, you will play a vital role in driving physician awareness...
...southern West Virginia employing more than 100 employees during the construction months. As a stone producer with multiple locations located... ...enterprise. Job Description Summary ~ A skilled electrician is needed to troubleshoot mechanical and electrical systems...