Analyst Reg Aff

Position Summary

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 Responsibilities

Execute 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 & Experience

Education: 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 Interactions

Internal: Functional areas including Quality, CLS, Tenders, Human Resources, and Commercial teams.

External: Industry Associations, Health Authorities, and Regulatory Consultants.

Core Competencies

Applied 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.