Intern - Regulatory Affairs

Remote (Hybrid with proximity to Northern Colorado preferred)

About Tolmar

Are you interested in learning new skills, exploring pharmaceutical research and manufacturing, networking with experts, and building a resume that opens doors? Join us to jumpstart your career! At Tolmar, you will connect with like-minded professionals in a supportive community. This is a place where you can make a meaningful impact and feel empowered by the abundant opportunities for growth.

Tolmar, Inc. is a fully integrated pharmaceutical company based in Colorado. We develop, manufacture, and distribute both branded and generic prescription medications globally, focusing on oncology, urology, and pediatric endocrinology. Our long-acting injectables and oral medications offer innovative treatment options that meet the diverse needs of patients worldwide. By leveraging emerging technologies and developing new products, we aim to simplify treatment delivery and enhance the overall patient experience.

About Regulatory Operations

Regulatory Operations is a systems-based function within Regulatory Affairs that enables health authority submissions and ongoing regulatory compliance through standardized processes and operational excellence. The Regulatory Operations group is responsible for meeting submission technical requirements, managing Regulatory Information and monitoring global Regulatory Intelligence.

Proposed Work Description

The nature of business is that priorities can shift according to the needs of the company/department and therefore the work described below is a sampling of the kinds of work we expect this position to entail:

• A Regulatory Operations intern will gain handson experience with the operational and technical aspects of regulatory submissions and regulatory systems. The internship provides exposure to eCTD submission workflows, regulatory information management practices, and regulatory intelligence processes, offering a practical understanding of how regulatory operations supports compliance and submission readiness in a regulated pharmaceutical environment.
• Train with publishers and assist with document preparation by ensuring each document meets all FDA PDF Specifications. Work inside our Regulatory Information Management System, supporting Tolmar projects and products by maintaining Health Authority Correspondence and Submission Archives. Learn about our Regulatory Intelligence Program and how Tolmar uses an AI Platform (RegAsk) to monitor global intelligence. The intern will assist with initiatives to further widen the scope of these systems, assisting with data entry and creating processes and helping author best practices.

Knowledge, Skills & Abilities

• Ability to interact collaboratively and effectively in a team environment.
• Proficient computer skills and comfort with learning new systems and platforms.
• Strong attention to detail with the ability to follow established processes, technical instructions, and quality standards
• Awareness of regulatory submissions and electronic document standards (e.g., eCTD, PDF specifications) or willingness to learn technical regulatory requirements.
• Demonstrated experience in working with Microsoft Suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe.
• Ability to work independently when needed.
• Ability to manage and prioritize multiple projects and tasks demonstrating strong organization and time management skills; to work in a fast-paced environment.

Core Values

The Intern is expected to work within the framework of Tolmar's Core Values:

• Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity,inclusion& sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Pursuing a college degree in a scientific or technical field.

Working Conditions

• Working conditions are normal for an office environment.
• Work is performed primarily remotely. The intern must have access to a private, quiet working area during business hours (8 AM-5 PM Mountain Time).

Compensation and Benefits

• Base rate is $19.00 per hour
• Benefits include medical insurance and 401k participation
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  Benefits summary: https://www.tolmar.com/careers/employee-benefits

  
  

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidate's qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.