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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Lima, PeruJob Description:
Execute regulatory strategies for the preparation and submission of renewal applications, variations, and new registrations for medical devices in compliance with country-specific regulations and the company's commercial plans. This role is intended to develop capabilities that enable greater contribution while working under close supervision.
Key ResponsibilitiesExecute end-to-end (E2E) regulatory strategies in compliance with applicable country-specific legislation and internal requirements, preparing the necessary submission dossiers to support the company’s business needs.
Maintain clear and timely communication with team members regarding process status and any potential risks or issues requiring escalation.
Coordinate regulatory submissions with Regulatory Affairs consultants in the countries associated with the assigned processes.
Maintain accurate and up-to-date databases for all assigned regulatory processes.
Actively participate in monthly planning meetings and prepare and submit regulatory dossiers in accordance with committed timelines.
Support Regulatory Affairs team members in addressing questions regarding local legislation and provide guidance from the perspective of the local regulatory authority.
Prepare timely responses to deficiency letters and additional information requests issued by health authorities for assigned regulatory processes.
Provide regulatory support to the local commercial, tender, and cross-functional teams by addressing questions related to medical device regulations in the country.
Provide support on health registration matters during inspections conducted by local or international regulatory authorities.
Conduct in-person or virtual follow-up with local health authorities to facilitate regulatory procedures, resolve questions, and propose solutions with relevant government representatives, as needed.
Perform other duties as assigned by the direct supervisor or manager.
Education & ExperienceEducation: Degree in Pharmaceutical Sciences, Medical Sciences, Chemical Sciences, or equivalent experience.
Experience: Previous experience in Regulatory Affairs and multi-country regulatory environments.
English Proficiency: Approximately 70%.
Key Stakeholder InteractionsInternal: Functional areas including Quality, CLS, Tenders, Human Resources, and Commercial teams.
External: Industry Associations, Health Authorities, and Regulatory Consultants.
Core CompetenciesApplied Technical Knowledge, Decision Making and Prioritization, Persuasive Communication, External Focus, Leading and Influencing, Business Acumen, and alignment with the Johnson & Johnson Leadership Imperatives: Credo, Deliver, and Connect.
Required Skills:
Preferred Skills:
Skills Required
- Degree in Pharmaceutical Sciences, Medical Sciences, Chemical Sciences, or equivalent experience
- Previous experience in Regulatory Affairs
- Experience working in multi-country regulatory environments
- Approximately 70% English proficiency
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
