Regulatory Associate I (Colorado-Hybrid)

Purpose and Scope

Under supervision of manager, perform all functions pertaining to FDA and Canadian requirements with regards to labeling and advertising and promotion for Tolmar’s products, including review of documentation, preparation of documents, compilation clinical and labeling related submissions. Support regulatory strategy activities in support of projects that require clinical RA input as required.

Essential Duties & Responsibilities

• Partner with Medical Affairs and the commercial teams to ensure promotional messaging accurately reflects clinical evidence and intended product use ensuring materials comply with applicable FDA had Health Canada regulations and internal company policies.
• Assist in developing, updating, and maintaining product labeling and core CCDS documents.
• Coordinate and prepare all regulatory submissions in relation to labeling and 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 back up RA representation on project teams where nonclinical/clinical RA support is needed. Offer 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.

Knowledge, Skills & Abilities

• 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.

Core Values

This position is expected to operate 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

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

Working Conditions

• Working conditions are normal for an office environment.
• Remote

Compensation and Benefits

• Annual pay range $70,000 to $85,000 depending on experience
• Benefits information:

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 candidates 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.