RA Professional Lifecycle Subm Eur

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Product Submissions and Registration

Job Category

Professional

All Job Posting Locations

Warsaw, Masovian, Poland

Job Description

• Perform lifecycle management activities per established processes and countryspecific requirements.

• o Propose strategy and timeline for National Procedure (NP) to the LOC. Liaise with
• Regional Regulatory Responsible (RRR) on strategies and timelines where
• applicable.
• o Prepare submission-ready documents/dossier(s) and ensure timely submission of
• high-quality (response) dossier.
• o Process Health Authority (HA) approvals to initiate post-approval activities
• promptly.

• Ensure timely update of databases throughout lifecycle management.
• Involve C-ROSS colleagues and external stakeholders at appropriate process

steps.

• Proactively monitor from end-to-end perspective regarding timely completion of

lifecycle management activities and escalate issues.

• Actively engage in internal process improvement initiatives and contributing to the

implementation of new regional/local requirements, tools, and systems

Required Skills

Preferred Skills

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented