Senior Public Affairs Director

Edelman Smithfield; Buenos Aires; On-site; ARS 77,270,000 - 123,632,000; Full time

Job summary

Edelman Smithfield is seeking a Regulatory Affairs Analyst to support regulatory submissions for clinical trials and marketing authorizations across Latin America.

The role involves working on small projects under supervision, tracking timelines, and preparing documentation in areas like CMC, labeling, and publishing. Strong English and excellent communication are essential.

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, Publishing, and Submission Publishing activities.
• Fluent English (writing, speaking, reading).
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical).
• Strong interpersonal communication and organizational 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 supervision.
• Ability to follow SOPs and contribute to process improvements.
• Ability to make decisions on discrete tasks under supervision.
• Requires advanced knowledge within a specific discipline.
• Makes adjustments or recommended enhancements in systems and processes to solve problems.
• Applicable certifications and licenses as required by regulatory bodies.

Responsibilities

• Acts as a Regulatory Team Member on small, straightforward regulatory projects under guidance.
• Identifies project needs, tracks timelines, and manages day-to-day workload with senior staff.
• Regulatory knowledge across CMC, Lifecycle Maintenance, MA transfers, labeling and publishing.
• Prepares and/or reviews regulatory documentation in area of expertise.
• Participates in project teams with internal and external customers and communicates confidently.
• Understands the Scope of Work and deliverables for each project.
• May prepare slides for small business development meetings and present to clients by phone or in person.
• May deliver trainings as appropriate.
• Performs other tasks as delegated by Regulatory management.
• Makes minor changes in systems and processes to solve problems not typically complex.

Skills

Fluent English

Interpersonal skills

Organizational skills

Project management

Regulatory knowledge

Education

Bachelor's Degree in Lifescience

Master's Degree in Lifescience (plus)

Tools

Microsoft Office

Publishing tools

Job description

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.

EEO Minorities/Females/Protected Veterans/Disabled