Exp RA Professional Lifecycle Submission

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

• Cross-Regional Operations & Strategic Support (C-ROSS) is a regional capability
• driven Regulatory Affairs organization working in close collaboration with Local
• Operation Companies (LOC), regional and global teams.
• The responsibility of C-ROSS Lifecycle Submissions is to coordinate lifecycle
• management procedures in-scope from end to end, ensuring timely submission,
• implementation of the change in the applicable databases and, if applicable, artwork.

• Established and productive individual contributor, who works under moderate

supervision.

• Helps establish and implement cost effective, results based, and professionally

• managed programs and innovative initiatives for the business area, under general
• supervision.

• Contributes to components of projects, programs, or processes for the business

area.

• Conducts routine risk assessments and establishes processes to mitigate those

risks under limited supervision within the business function.

• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives

in day-to-day interactions with team.

• Perform lifecycle management activities per established processes and country-specific requirements for TURGAN .

• 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, 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

The anticipated base pay range for this position is

zł145,800.00 - zł234,600.00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.