Regulatory Affairs Analyst

Bogota, Colombia
Mexico City, Mexico
Buenos Aires, Argentina
Full time
R

Job Overview

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

Essential Functions

- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable.
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
- Understands the Scope of Work, deliverables for any given project.
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person.
- May prepare and deliver trainings, as appropriate.
- Performs other tasks or assignments, as delegated by Regulatory management.
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.

Qualifications





- Bachelor's Degree in Lifescience or related discipline (concluded).
- Master's Degree in Lifescience or related discipline is a plus.
- At least 2 - 3 years relevant experience in Regulatory Affairs in general, Publishing, Word Formatting, Clinical PDF Publishing, Submission Publishing activities.
- Fluent English (writing, speaking, reading).
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
- Good, solid interpersonal communication (oral and written) 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, as applicable.
- Demonstrates self-motivation and enthusiasm.
- Ability to work on several projects, with direction from senior staff as appropriate.
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements.
- Ability to make decisions on discrete tasks under senior supervision.
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex.
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

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