Regulatory Affairs Specialist – LatAm

7257 Syneos Health Argentina S.A.; Partido de Quilmes; Presencial; ARS 91.385.000 - 137.078.000; Jornada completa

Descripción de la vacante

Syneos Health Argentina S.A. in Argentina seeks a Regulatory Affairs Officer (Mid Level) to support regulatory submissions for trials and marketing authorizations across multiple regions.

You will work with senior staff, prepare documentation, and help manage project timelines. Ideal candidates hold a Life Sciences degree, 2–3 years of regulatory experience, fluent English, strong communication, and organization skills; US/Canada exposure is a plus.

Formación

• Bachelor's degree in Lifescience or related discipline.
• 2–3 years of regulatory affairs (post‑marketing) experience: maintenance records, new records, regulatory activities.
• 1 year tracking information on regulatory processes.
• Fluent English: spoken, read and written.
• It’s a plus to have worked with other countries: USA, Canada.
• 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.
• Demonstrates self‑motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating procedures 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.

Responsabilidades

• 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;

Conocimientos

Fluent English

Interpersonal skills

Regulatory knowledge

Organization skills

Educación

Bachelor's degree in Life Sciences

Herramientas

Microsoft Office

Publishing tools

Descripción del empleo

Syneos Health Argentina S.A. in Argentina seeks a Regulatory Affairs Officer (Mid Level) to support regulatory submissions for trials and marketing authorizations across multiple regions.

You will work with senior staff, prepare documentation, and help manage project timelines. Ideal candidates hold a Life Sciences degree, 2–3 years of regulatory experience, fluent English, strong communication, and organization skills; US/Canada exposure is a plus.