At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
ERMC Regulatory Affairs Lifecycle Management
Location: Belgrade, Serbia
The Regulatory Management Center (RMC) is a regional organization responsible for most of the operational regulatory maintenance activities, acting on behalf of LOCs and led by senior regulatory staff. The RMC handles tactical Lifecycle Management (LCM) processes for CMC variations and Labeling changes in the region. The RMC is embedded in the AP, EMEA and LA regional organizations and works in close collaboration with the respective LOCs and regional/ global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports).
The responsibility of the ERMC RA Lifecycle Management (LCM) is to coordinate a broad range of product lifecycle changes for multiple countries in the EMEA region, from planning of the submission up to implementation of the change in the applicable databases and, if applicable, artwork.
The current job opening is for a LCM RA Professional for the Non EEA region (containing Middle East, Africa, Turkey, Russia/CIS, Switzerland and Central East European countries outside of the EU) with Switzerland as the Main scope for this post at the moment.
Janssen is looking for a talented, experienced regulatory affairs professional to join the EMEA RMC (ERMC) team. The role is to focus primarily on the coordination of procedures within the ERMC team; ensuring compliant, high quality and timely submissions to the Health Authorities for lifecycle management activities for Janssen products. The successful candidate will be dedicated to a cluster of countries and will work closely together with local and regional project teams.
The ideal candidate will bring in this role a high level of awareness of the applicable regulatory environment. The candidate will further require a pro-active attitude, problem-solving capabilities and excellent communication skills.
YOUR responsibilities & YOUR impact:
- Coordinate lifecycle maintenance procedures (mostly CMC variations and Labeling changes) in-scope of ERMC, plus any other regulatory procedure as assigned to ERMC in agreement with the ERMC Head.
- Coordinate procedures from planning through to global dispatch, submission, HA approval and implementation in the applicable databases and artwork, where applicable.
- Liaise with LOC to set submission strategy and timelines for NP activities.
- Liaise with EMEA Liaison, CMC-RA and/or LOC for preparation of submission-ready documents or dossier(s).
- Ensure timely submission of a good-quality (response) dossier.
- Manage validation issues or HA questions and prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC.
- Process HA approvals appropriately, to allow implementation steps and other post-approval activities to be initiated in a timely manner.
- Finalize/archive applicable documents/tools as soon as post-approval activities are completed, changes are implemented in artwork (if applicable) and databases are closed.
- Involve ERMC colleagues for specific process steps like completion of databases, preparation of local PI and/or preparation of artwork. LCM RA professional is responsible to provide correct triggers at the correct time; however, 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 described in RIACS (local regulations and country specific requirements as provided to us by the LOCs) and in alignment with the LOCs.
- Perform all lifecycle management activities by following ERMC processes, templates and other applicable guidance documents implemented for the LCM team specifically or the ERMC team in general.
- Act as backup LCM for assigned procedures/countries/cluster(s) in urgent cases and/or as assigned by ERMC LCM sub-team Lead or ERMC LCM Lead, to ensure quality/ continuity of all lifecycle management activities.
- Act as mentor for new LCM colleagues, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
- Lead projects for LCM and/or act as a subject matter expert, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
- Ensure regulatory compliance of the Lifecycle Management activities and participate in audit-readiness activities where required
We would love to hear from YOU, if you have:
- A minimum of a University degree or equivalent by experience
- At least 3 years of regulatory affairs experience
- In depth knowledge of local and regional regulations/legislation
- Experience in regulatory Lifecycle Management, in co-operation with HAs
The following experience is seen as an advantage:
- Working in a virtual environment
- Experience in a global organization
- Experience in a local affiliate organization
- Experience in working with limited supervision and able to make independent decisions
- Excellent verbal and written communication skills
- Proficiency in written and oral English
- German language is an advantage
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment
- Proactive team player, able to take charge and follow-through
- Achievement-oriented with a high degree of flexibility and ability to adapt to a changing (regulatory) environment
- Proficient use of technology including RA tracking systems is preferred
- The position is in the LOC of the respective country/region or in a TA-hub in the EMEA region. No relocation is required.
- The candidate must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.
- Occasional international travel (~ 2x per year) may be required.
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees’ benefits.
Johnson & Johnson d.o.o. Ogranak u Beogradu (8392).