Regulatory Affairs Sr Specialist - Latam

Johnson & Johnson; Buenos Aires; Presencial; USD 50.000 - 90.000; Jornada completa

Descripción de la vacante

An established industry player is on the lookout for a Regulatory Affairs Sr Specialist to join their LATAM team. This role is pivotal in ensuring compliance with regulations across multiple countries, including Argentina, Brazil, and Mexico. You will leverage your expertise in regulatory documentation to support product registration and lifecycle management. With a focus on collaboration and analytical skills, you will play a crucial role in shaping the future of healthcare. If you are driven by results and have a passion for regulatory affairs, this opportunity could be your next career milestone.

Formación

• 3-4 years in Regulatory Environment, especially in Medical Devices or Pharma.
• Experience in dossier creation and submissions.

Responsabilidades

• Prepare registration dossiers for new products and renewals.
• Analyze country requirements and ensure compliance with regulations.

Conocimientos

Collaboration

Analytical Skills

Interpersonal Skills

Regulatory Knowledge

Educación

Bachelor's in Engineering

Bachelor's in Pharmacy

Advanced Degree

Herramientas

PC Skills

Descripción del empleo

Regulatory Affairs Sr Specialist - Latam

Johnson & Johnson

REGULATORY AFFAIRS SR SPECIALIST - LATAM

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, impacting the health of over 1 billion patients and consumers daily for more than 130 years. We welcome all individuals regardless of race, belief, sexual orientation, religion, or any other trait to apply for open positions.

Joining Johnson & Johnson could be your next big move, potentially leading to breakthroughs in health. Our Medical Devices Companies are leveraging our scale and expertise to reinvent healthcare delivery, helping people live longer, healthier lives. In a rapidly changing environment, we connect science and technology to develop doctor and patient-centric products and solutions.

We are seeking a Regulatory Affairs Sr Specialist for LATAM markets, including Argentina, Brazil, Mexico, Colombia, or Peru.

Purpose

You will serve as a consultant and technical expert on documentation required for submissions across multiple business units and countries within the Medical Device sector of Johnson & Johnson for LATAM markets.

Major Roles and Responsibilities

• Participate actively and deliver results timely within RA teams to meet shared goals and strategies.
• Prepare registration dossiers for new products, product development, changes, and renewals.
• Review and assess documentation to ensure compliance with country regulations.
• Analyze country requirements to identify trends and changes in regulation.
• Consult with internal partners regarding submission requirements and standards to facilitate efficient processing by health authorities.
• Serve as SME on documentation and regulation to ensure understanding of country needs.
• Implement Regulatory Affairs strategies aligned with business goals, considering benefits and risks.
• Lead projects within the team, managing complex and ambiguous information.
• Assist in developing standard methodologies for Regulatory Affairs processes.
• Support strategy development for product registration and lifecycle management across LATAM.
• Coordinate multiple projects simultaneously, ensuring compliance with regulations.

Qualifications

Education: Bachelor's in Engineering, Pharmacy, or related life sciences; advanced degrees preferred.

Experience: 3-4 years in Regulatory Environment, with experience in Medical Devices or Pharma, including dossier creation and submissions.

Capabilities: Collaboration, results-driven, sense of urgency, integrity, curiosity, organization, and talent development.

Knowledge: LATAM regulations, dossier creation, PC skills, analytical skills, compliance importance, interpersonal skills.

Languages: Advanced English and Spanish.

Role Type: Individual contributor / Regional position.

Travel: 0-5%

Reports to: RA Manager

Location: Argentina, Brazil, Mexico, Peru, or Colombia.

We are an equal opportunity employer and value diversity, welcoming applicants regardless of race, religion, gender, age, or disability.