Purpose and Scope
Under supervision, assist in all functions pertaining to domestic and international regulatory submissions, including preparation of documents for electronic or paper filing for drug projects. This includes working on project teams to guide development to meet regulatory registration requirements.
Essential Duties & Responsibilities
- Represent and serve as regulatory representative in project team meetings with consultation. Offer regulatory opinions with consultation from regulatory management.
- Assist regulatory management and team with tracking and driving timelines
- Review and approve all controlled documents with minimal mentorship.
- Create and review routine submission documentation with minimal mentorship.
- Coordinate with personnel from other departments to obtain data/documentation for submissions with guidance from the manager.
- Review new and existing procedures with mentorship.
- Keep current with global health authority regulations/guidelines.
- Conform to regulatory department standards and compliance with GMP.
- Perform various other duties as assigned.
Knowledge, Skills & Abilities
- Proficient knowledge of word processing, specifically MS Office Suite, and Adobe Reader/Writer.
- Knowledge of Database Management software.
- Excellent writing and organizational skills.
- Ability to coordinate information from various internal and external disciplines.
- Ability to understand regulatory and technical concepts and requirements.
- Ability to perform multiple tasks on several projects.
- Ability to prepare written summaries of technical data suitable for inclusion in regulatory submissions.
- Ability to understand, and comply with domestic and international regulatory requirements.
- Ability to follow specific directions and to request instructions for complex tasks.
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 and treat 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 with an enterprise‑wide mindset that lifts the whole organization.
- 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- 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 required, preferred in a scientific field.
- Two or more years’ in regulatory or four years’ applicable pharmaceutical industry experience with knowledge and experience in preparing and submitting regulatory dossiers/applications to regulatory agencies.
Working Conditions
- Working conditions are consistent with a normal office environment and/or remotely from home office.
- Some travel may be required.
Compensation and 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 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.
