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Location

Aurora, CO | United States

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Job description

Are you passionate about making a difference in the pharmaceutical industry? Do you thrive in a dynamic environment where your expertise is valued? We are seeking a dedicated Clinical Product Regulatory Specialist to join our innovative team!

As a Clinical Product Regulatory Specialist, you'll play a crucial role in managing regulatory and investigational product activities to support our exciting clinical trials. You'll have the opportunity to shape internal processes, collaborate with external partners, and ensure compliance with regulatory standards to bring life-changing treatments to patients worldwide.

Responsibilities:

Regulatory Champion:

Ensure adherence to regulatory requirements set forth by the FDA and other relevant agencies, fostering strong relationships with regulatory bodies both domestically and internationally.
Serve as a liaison between regulatory agencies and our organization, ensuring seamless communication and compliance.
Maintain accurate and up-to-date documentation to support regulatory submissions and approvals.
Provide regulatory support to our Operations teams, ensuring all trials meet regulatory standards.
Actively report adverse events to regulatory authorities and review site-level regulatory documents.
Supply Management Extraordinaire:

Oversee the coordination of investigational product lifecycle activities, from importation to destruction, ensuring seamless supply chain management.
Develop and maintain strong relationships with external partners to facilitate product labeling, distribution, and certification.
Monitor inventory levels and take proactive measures to prevent supply issues throughout the trial process.
Collaborate with Quality Assurance to ensure proper documentation and approval of batch records.
Manage product returns and destruction processes, maintaining meticulous documentation.
Assist in the selection and contracting of Interactive Response Technology providers.
Qualifications:

Bachelor's degree or higher in health or life sciences.
Minimum of 5 years' experience in pharmaceutical/biotechnology industry with a focus on international clinical trial regulatory management.
Experience interpreting clinical trial protocols and interacting with drug depots.
Knowledge of safety reporting regulations, GMP, GCP, and ICH guidelines.
Proficiency in MS Office and Electronic Data Capture systems.
Excellent communication and leadership skills, with a keen attention to detail.
Ability to work collaboratively in a team environment and mentor others effectively.
Join us in our mission to revolutionize clinical research and bring hope to patients worldwide! We offer a competitive compensation package, comprehensive benefits, flexible work schedules, and a vibrant, inclusive work culture. Apply now and be part of our dynamic team!
Employment Type: Full-Time
Salary: $ 90,000.00 Per Year

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