Description
We are seeking a Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will provide regulatory support for assigned projects, prepare and review regulatory submissions documents to support clinical trial and marketing authorization activities for internal and external clients.
Essential Functions
- Act as a Regulatory Team Member on small, straightforward regulatory projects and get involved in small single-service projects under senior staff guidance.
- Identify project needs, track project timelines, implement client requests, and manage day-to-day workload in collaboration with senior staff.
- Utilize regulatory knowledge in Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Publishing as applicable.
- Prepare and review regulatory documentation in areas of expertise.
- Participate in project teams with internal and external customers independently and communicate confidently in straightforward matters.
- Understand the Scope of Work and deliverables for given projects.
- Prepare slides and background material for small business development meetings under senior guidance and present in client meetings by phone or in person.
- Prepare and deliver trainings as needed.
- Perform other tasks or assignments delegated by Regulatory management.
- Make minor changes in systems and processes to solve problems.
Qualifications
- Bachelor's Degree in Life Sciences or related discipline.
- Master's Degree in Life Sciences or related discipline is a plus.
- At least 2-3 years of relevant experience in Regulatory Affairs, Publishing, Word Formatting, Clinical PDF Publishing, and Submission Publishing activities.
- Fluent English (writing, speaking, reading).
- Good understanding of the Research and Development process, laws, and related guidelines.
- Solid interpersonal communication and organization skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Strong software and computer skills, including Microsoft Office, publishing applications, and tools.
- Demonstrates self-motivation and enthusiasm.
- Ability to work on several projects with direction from senior staff.
- Ability to follow standard operating procedures consistently and provide independent thought to assist in process improvements.
- Ability to make decisions on discrete tasks under senior supervision.