Regulatory Affairs Specialist

Overview

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

The Opportunity

Initiate the registrations and maintain the products local label through coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements. As well as monitoring and maintaining their tracking systems.

Responsibilities

• Develop innovative risk-based registration plans and submissions strategies for Affiliate products with guidance from DRA Management.
• Interact with local authorities for DRA submission matters (New Registrations, Variations, Renewals and Sites maintenance).
• Prepare communications with local authorities (FDA MOH and MISA) whilst submission of communication and appointments through their portals.
• Monitor and track regulatory filings status and communicate status to other Affiliate DRA colleagues.
• Adapt global product dossiers to local requirements.
• Ensure timely filing submissions of new registrations and site renewals into the local authorities portal.
• Interact with global and local teams for Patient Information Leaflet (PIL) updates site renewal and product renewal.
• Ensure accurate timely and thorough data entry for Affiliate regulatory activities on relevant Roche systems.
• Ensure regulatory inspection-readiness for the Affiliate as per assigned responsibilities.
• Ensure regulatory compliance for product released to market according to marketing.

Who you are

Who we are

A healthier future drives us to innovate. Together more than employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience

Unclear Seniority

Key Skills

Employment Details

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