Experienced RA Professional ERMC Submissions

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 https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Cairo, Egypt

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Experienced RA Professional ERMC Submissions to be in Cairo, Egypt.

The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for majority of the operational regulatory maintenance activities, acting on behalf of Local Operating Companies (LOCs) and works in close collaboration with the respective LOCs, regional and global teams.

The responsibility of ERMC Submission Excellence is to coordinate lifecycle management procedures in-scope of ERMC from end to end, ensuring timely submission, implementation of the change in the applicable databases and, if applicable, artwork.

The successful candidate is an established and productive individual contributor who works under moderate supervision, helping to establish and implement cost-effective, results-based, and professionally managed programs and innovative initiatives for the business area under general supervision; The Regulatory Affairs professional contributes to components of projects, programs, or processes for the business area; This professional conducts routine risk assessments and establishes processes to mitigate those risks under limited supervision within the business function; The candidate understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with the team.

Main duties and responsibilities:


* Perform lifecycle management activities per established processes and country-specific requirements.


* Propose strategy and timeline for National Procedure (NP) to the LOC.


* Prepare submission-ready documents/dossier(s) and ensure timely submission of high-quality (response) dossier.


* Process Health Authority (HA) approvals to initiate post-approval activities promptly.


* E...