Roche

Healthcare

RegulatoryProgramSpecialist(Temporary-Secondment)

$14000–20000k ~AI est. San Jose, Costa Rica FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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

Free ATS check

Applying for this Regulatory Program Specialist (Temporary-Secondment) role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Workday

  • Workday has a multi-step form — save your progress after every section.
  • "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
  • Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
  • Job requisition numbers are useful when following up with HR by email.

ANONYMOUS · UNFILTERED

What do employees actually say about Roche?

Real rants from real employees. Read before you apply.

Read Company Rants →