Regulatory Affairs Specialist (Temporary)

Descrizione del lavoro:

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

Relocation benefits are not available for this job posting. This will be a temporary contract for 1 year.

Position summary: Individual contributor regulatory professional in PTR who continuously deepens regulatory expertise and boldly innovates to deliver "one submission, one approval" worldwide by partnering across functions (molecule teams, affiliates, policy, and key initiatives) to shape the regulatory/technical environment, maintain licenses and GxP/Code of Conduct compliance, and enable a flexible, efficient, and thriving organization that meets evolving business and patient needs.

The Opportunity:
* Accountable for global planning, tracking, and monitoring of key regulatory information to ensure internal/external compliance and effective execution of submissions.
* Participate in developing and implementing the regulatory data strategy and configuring submission data in regulatory information management systems, including partnering with PT, PD, pRED and gRED to enable a single regulatory data strategy and data flow across the systems environment.
* Execute end-to-end submission-support activities: perform defined steps in the submission process, edit/format technical documents (e.g., eCTD) to Roche/HA standards, coordinate document flow and version control in DMS, and partner with PTR Squad Members to plan, track, and deliver content on time while liaising with technical SMEs.
* Contribute to continuous improvement by providing input on future system enhancements, business process updates, submission model documents, and by managing/reporting regulatory data across regions and sites, including work with external vendors (e.g., OBE Vendor Alliance) and use of submission/RIM tools and technologies.
* Serve as Business Process Owner and/or Subject Matter Expert for specific regulatory information activities and technologies, including defining and maintaining regulatory master data to uphold Roche/HA data governance standards globally, developing process documentation, and delivering training as needed.

Who you are
* Applies in-depth knowledge of Roche and regulatory guidelines, laws, and best practices to perform complex system searches, prepare/analyze reports, assemble documentation, and ensure compliance with regulations, company policies, and business processes.
* Builds and maintains productive, trusted relationships across departments and with external partners/regulators; acts as a key resource/mentor for junior colleagues, including on sensitive cases, and supports project activities.
* Demonstrates a continuous improvement and learning mindset: stays abreast of internal/external developments, understands regulatory strategy and processes, adapts to change, and proactively seeks opportunities to learn and apply new skills across a broader range of deliverables.
* Influences team processes, project outcomes, and customer activities by driving internal and external awareness of regulations and contributing expertise to regulatory and operational decisions.
* Brings 1-2+ years' experience in a similar role, preferably with a BA/BS (or equivalent) in English, biology, chemistry, pharmacy, a related field, or a lab-assistant degree (e.g., CTA, BTA, PTA).​

Please note: Resumes must be submitted in English, as our interview panel may include participants from outside your local country.

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Who we are

A healthier future drives us to innovate. Together, more than 100'000 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 life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer