Regulatory Affairs Talent Pool

Roche

0-2 years

Not Disclosed

Budapest Remote

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs TALENT POOL

Location: Budapest, Pest, Hungary
Category: Regulatory Affairs
Job ID: 202411-129170

Position Overview

At Roche, we strive to be a company where diversity, equity, and inclusion are fundamental values, and we believe this diversity fosters innovation in healthcare. The Regulatory Operations Group is an integral part of our Product Development Regulatory (PDR) organization. It interprets the needs of health authorities and provides the regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers, and prescribers.

As part of this group, you will contribute to the timely submission of regulatory applications and play a key role in the coordination, compilation, publishing, and submissions expertise needed to prepare and support new and existing regulatory applications.

Key Responsibilities

Coordination & Compilation:
- Provide coordination and compilation expertise for regulatory documents, ensuring accurate and complete information is available for stakeholders.
- Assist in the preparation, formatting, and maintenance of regulatory documents within document management systems.
Regulatory Submissions & Dossiers:
- Compile regulatory submission dossiers and hand them over to publishing, ensuring compliance with regulatory standards.
- Ensure that all regulatory information in systems is accurate, complete, and relevant to stakeholders' needs.
Process Improvement & Mentoring:
- Continuously strive to improve process efficiency and service quality.
- Mentor new team members or colleagues by sharing knowledge and best practices.
Cross-Team Collaboration:
- Build and nurture a wide network within different operational teams to ensure smooth collaboration across functions.
Support for Global Labeling:
- Ensure the development and maintenance of scientifically-sound, evidence-based, and balanced labels for Roche’s medicines.

Your Profile

Educational Background:
- Relevant qualifications in Regulatory Affairs, Pharmacy, Life Sciences, or a related field.
Experience:
- Previous experience in Regulatory Affairs or a related role is desirable but not required.
- Experience in Regulatory Submissions, Clinical Trials, or Regulatory Operations would be advantageous.
Skills and Competencies:
- Strong ability to collaborate across teams and departments.
- Excellent organizational and communication skills with a keen eye for detail.
- Ability to work independently and manage multiple tasks efficiently in a fast-paced environment.
- Eagerness to learn and grow professionally in the regulatory space.
- A growth mindset with the drive to continuously improve processes and support high-quality service delivery.

What Roche Offers You

Career Development:
- Roche provides opportunities to build exceptional professional knowledge in regulatory submissions and clinical trials.
- Mentoring and knowledge-sharing opportunities, including training new team members.
Diverse and Inclusive Work Environment:
- Work alongside a diverse team with various educational backgrounds and levels of experience, providing a collaborative and enriching environment.
Improvement and Efficiency Focus:
- Actively contribute to continuous improvement in regulatory operations and enhance service quality.

Why Roche?

By joining Roche, you will become part of a global organization with a focus on improving patient outcomes. You will have the opportunity to be part of a company that values collaboration, diversity, and inclusion and strives to create high-quality medicines that benefit patients and healthcare systems worldwide.

How to Apply

If you’re passionate about Regulatory Affairs and are excited by the opportunity to work in a challenging and rewarding environment, apply today.

We look forward to hearing from you!

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