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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Porto Salvo, Portugal

Job Description:

Experienced Regulatory Affairs Professional – C‑ROSS Lifecycle Submissions (LS)

The C‑ROSS Lifecycle Submissions (LS) team is a regional Regulatory Affairs organization responsible for the majority of operational regulatory maintenance activities on behalf of Local Operating Companies (LOCs). The team works in close partnership with LOCs, as well as regional and global stakeholders, to ensure high‑quality and timely execution of lifecycle management procedures.

In this role, you will coordinate end‑to‑end lifecycle submissions within the C‑ROSS scope, ensuring timely submissions, proper implementation of changes in relevant systems and databases, and—where applicable—completion of artwork updates.

Key Responsibilities

• Execute lifecycle management activities in line with established processes and country‑specific regulatory requirements.

  • Develop and propose regulatory strategies and timelines for National Procedures (NPs) to the LOC.

  • Prepare submission‑ready dossiers and documentation, ensuring high‑quality and timely submissions, including responses.

  • Process Health Authority approvals promptly to enable post‑approval activities.

• Maintain regulatory databases with accurate and timely updates throughout the product lifecycle.

• Collaborate effectively by involving relevant C‑ROSS colleagues and external partners at the appropriate stages of the process.

• Monitor end‑to‑end progress of lifecycle activities, proactively identifying delays or risks and escalating issues as needed.

• Contribute to continuous improvement, actively participating in initiatives to enhance processes, tools, and systems, and supporting the implementation of new regional or local requirements.

Additional Requirements

This position supports regulatory submissions in Israel. Therefore, fluency in Hebrew (reading and writing) is a mandatory requirement.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented