Exp RA Professional Lifecycle Submission

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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 & Johnsons 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:

zł145800.00 - zł234600.00

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 locations 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.