The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs
organization responsible for handling the majority of the operational
regulatory lifecycle activities for CMC and labeling changes, acting on behalf
of EMEA Local Operating Companies (LOCs), and is led by Senior Regulatory
Staff. The Center is embedded in the EMEA region, and works in close
collaboration with the respective Local Operating Companies and regional and
global departments.
Responsibilities :
- Enter and maintain data in global company Regulatory Databases within the specified timelines to ensure regulatory compliance, and that regulatory submissions are correctly reflected.
- Submit variation dossiers, including response to HA questions and eCTD closing sequences, in respective local HA portals, as applicable.
- Monitor and analyze metrics and reports to ensure the data in the systems is correctly reflected.
- Ensuring Compliance and Audit readiness.
- Liaise with stakeholders in other ERMC sub-teams as well as outside of ERMC, such as Local Operating Companies
Qualifications
Requirements:
- Previous experience of 2 years in Regulatory Affairs or equivalent
- Experience working in a virtual team and/or global organization would be an asset
- Experience in working with limited supervision and able to make independent decisions is of advantage
- Cultural sensitivity and ability to work and thrive in a multicultural environment
- Experience with computer systems usage (MS office, excel)
- Proficient level of English
- Accuracy, precision, and respect for timelines are mandatory
- Adequate sense for compliance is required
Johnson & Johnson Family of Companies are equal opportunity employers, and all
qualified applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity, genetic
information, national origin, protected veteran status, disability status, or
any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable
accommodation to participate in the job application or interview process, to
perform essential job functions, and to receive other benefits and privileges
of employment. Please contact us to request accommodation.