Roche
Healthcare
RegulatoryProgramSpecialist(Temporary-Secondment)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regulatory Program Specialist (Temporary-Secondment) at Roche. Skills: Regulatory program management, Submission execution, Data strategy. Plan, track, and monitor regulatory information. Develop and implement regulatory data strategy”
Industry & Context.
Complex system searches; Analyze reports
What They're Looking For.
Must Have
1-2+ years experience in similar role, BAS or equivalent in English, biology, chemistry, pharmacy, or related field, Lab-assistant degree (CTA, BTA, PTA)
What You'll Do.
and monitor regulatory information
Develop and implement regulatory data strategy
Configure submission data in RIM systems
Execute end-to-end submission-support activities
Edit and format technical documents
Coordinate document flow and version control
Manage and report regulatory data
Serve as Business Process Owner
Define and maintain regulatory master data
Develop process documentation
How You'll Work.
Team & Collaboration
Partner across functions; Partner with PT, PD, pRED, gRED; Partner with PTR Squad Members; Liaise with technical SMEs; Work with external vendors
Full Job Description
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, busin
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