Johnson & Johnson Services, Inc. is recruiting for a ERMC Regulatory Affairs Lifecycle Management, RAProfessional to be located in Istanbul, Turkey.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets.
There are more than 265 Johnson & Johnson operating companies employing approximately 130,000 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
And our culture is interconnected by the shared values of Our Credo . It’s a culture that celebrates diversity and diverse perspectives.
It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
ERMCRegulatory Affairs Lifecycle Management, RA Professional
The Regulatory Management Center (RMC) is a regionalorganization responsible for most of the operational regulatory maintenanceactivities, acting on behalf of LOCs and led by senior regulatory staff.
TheRMC handles tactical Lifecycle Management (LCM) processes for CMC variationsand Labeling changes in the region. The RMC is embedded in the AP, EMEA and LAregional organizations and works in close collaboration with the respective LOCsand regional / global departments.
The RMC is a virtual, dedicated team consisting of GRAregional team members (direct reports).
The responsibility of the ERMC RA Lifecycle Management(LCM) is to coordinate a broad range of product lifecycle changes for multiplecountries in the EMEA region, from planning of the submission up toimplementation of the change in the applicable databases and, if applicable,artwork.
The current job opening is for a LCM RA Professionalfor the Non-EEA region (containing Middle East, Africa, Russia / CIS and CentralEast European countries outside of the EU).
Janssen is looking for a talented, experiencedregulatory affairs professional to join the EMEA RMC (ERMC) team. The role isto focus primarily on the coordination of procedures within the ERMC team;
ensuring compliant, high quality and timely submissions to the HealthAuthorities for lifecycle management activities for Janssen products.
Thesuccessful candidate will be dedicated to a cluster of countries and will workclosely together with local and regional project teams
The ideal candidate will bring in this role a highlevel of awareness of the applicable regulatory environment. The candidate willfurther require a pro-active attitude, problem-solving capabilities andexcellent communication skills.
Coordinate lifecycle maintenance procedures (mostlyCMC variations and Labeling changes) in-scope of ERMC, plus any otherregulatory procedure as assigned to ERMC in agreement with the ERMC Head.
Coordinate procedures from planning through to globaldispatch, submission, HA approval and implementation in the applicabledatabases and artwork, where applicable.
Liaise with LOC to set submission strategy andtimelines for NP activities.
Liaise with EMEA Liaison, CMC-RA and / or LOC for preparationof submission-ready documents or dossier(s).
Ensure timely submission of a good-quality (response)dossier.
Manage validation issues or HA questions and prepareresponse documents / dossiers in alignment with EMEA Liaison, CMC-RA and / or LOC.
Process HA approvals appropriately, to allowimplementation steps and other post-approval activities to be initiated in atimely manner.
Finalize / archive applicable documents / tools as soon aspost-approval activities are completed, changes are implemented in artwork (ifapplicable) and databases are closed.
Involve ERMC colleagues for specific process stepslike completion of databases, preparation of local PI and / or preparation ofartwork.
The LCM RA Professional is responsible to provide correct triggers at thecorrect time, however the LCM RA Professional is not responsible for correct / timely completion of the tasks by the other ERMC sub-teams.
Perform all country specific activities as describedin RIACS (local regulations and country specific requirements as provided to usby the LOCs) and in alignment with the LOCs.
Perform all lifecycle management activities byfollowing ERMC processes, templates and other applicable guidance documentsimplemented for the LCM team specifically or the ERMC team in general.
Act as backup LCM for assignedprocedures / countries / cluster(s) in urgent cases and / or as assigned by ERMC LCM sub-teamLead or ERMC LCM Lead, to ensure quality / continuity of all lifecyclemanagement activities.
Act as mentor for new LCM colleagues, if so assignedby the EMEA LCM sub-team Lead or EMEA LCM Lead.
Lead projects for LCM and / or act as a subject matterexpert, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
Ensureregulatory compliance of the Lifecycle Management activities and participate inaudit-readiness activities where required.
A minimum of a University degree orequivalent by experience
At least 3 years of regulatoryaffairs experience
In depth knowledge of local andregional regulations / legislation
Experience in regulatory LifecycleManagement, in co-operation with HAs
The following experience is seen asan advantage :
Working in a virtual environment
Experience in a global organization
Experience in a local affiliateorganization
Experience in working with limitedsupervision and able to make independent decisions
Excellent verbal and written communicationskills
Proficiency in written and oralEnglish
Cultural sensitivity and ability towork and thrive in a multi-cultural environment
Proactive team player, able to takecharge and follow-through
Achievement-oriented with a highdegree of flexibility and ability to adapt to a changing (regulatory) environment
Proficient use of technologyincluding RA tracking systems is preferre
The position is in the LOC of the respectivecountry / region or in a TA-hub in the EMEA region. No relocation is required.
The candidate must be able to work flexible hours toaccommodate early morning / evening meetings / teleconferences with different timezones.
Occasional international travel ( 2x per year) may berequired.
Johnson & Johnson Sihhi Malzeme Ltd. (7347)