Regulatory Associate I (Colorado-Hybrid)

About the Role

Under supervision of a manager, perform all functions pertaining to FDA and Canadian requirements regarding labeling, advertising, and promotion for Tolmar’s products. This includes review of documentation, preparation of documents, and compilation of clinical and labeling-related submissions. Support regulatory strategy activities for projects requiring clinical regulatory input.

Responsibilities

• Partner with Medical Affairs and commercial teams to ensure promotional messaging accurately reflects clinical evidence and intended product use, complying with applicable FDA and Health Canada regulations and internal policies.
• Assist in developing, updating, and maintaining product labeling and core CCDS documents.
• Coordinate and prepare all regulatory submissions related to labeling, advertising, and promotion.
• Assist with the preparation, review, and coordination of clinical regulatory activities and submissions as required.
• Develop, maintain, and track clinical and labeling project timelines to ensure timely completion of deliverables and milestones.
• Serve as backup regulatory affairs representation on project teams where nonclinical/clinical support is needed, offering regulatory opinions with consultation from senior regulatory management.
• Coordinate with cross-functional teams to facilitate timely review, approval, and implementation of assigned regulatory activities.
• Perform various other duties as assigned.

Requirements

• Proficiency in Microsoft Office and Adobe Acrobat.
• Effective written and verbal communication skills, including the ability to summarize technical and scientific data for regulatory submissions.
• Strong organizational and project management skills, with the ability to manage multiple priorities simultaneously.
• Proficiency in maintaining timelines, trackers, and regulatory documentation.
• Ability to understand regulatory, technical, and scientific concepts and requirements.
• Ability to collaborate effectively with cross-functional internal and external teams.
• Ability to work independently with oversight while exercising sound judgment.
• Strong attention to detail and commitment to accuracy.

Qualifications

• Bachelor’s degree in a scientific field preferred.
• 1-2 years of experience in the pharmaceutical industry preferred.

Core Values

• Center on People: Commit to supporting the well-being of patients and treating employees and stakeholders as valued partners.
• Are Proactive & Agile: Embrace a culture of engagement and action, adapting fearlessly to change and driving extraordinary outcomes.
• Act Ethically: Conduct business ethically, compliantly, and with social awareness, fostering diversity, equity, inclusion, and sustainability.
• Constantly Improve: Collaborate proactively to improve products, systems, processes, and services by reducing waste and increasing efficiency.
• Are Accountable: Communicate with honesty, transparency, and clarity, taking ownership of work, actions, successes, and setbacks.

Working Conditions

Normal for an office environment. Remote work may be applicable.

Pay

Annual pay range: $70,000 to $85,000, depending on experience.

Benefits

Tolmar offers a strong benefits package. For more details, visit Tolmar’s employee benefits page.