RA Professional ERMC EUCP Labeling (1-year contract)
Publication date:
12 September 2024Workload:
5 – 100%Contract type:
Permanent position- Place of work:Johnson
Johnson & Johnson is recruiting for an ERMC EUCP Labeling RA Professional to be based in our office in Beerse, Belgium.
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/.
The key responsibility of the ERMC EUCP Labeling RA Professional is to coordinate labeling translations, linguistic review and submission of EU Product Information (EUPI) according to Health Authority and JnJ requirements.
Are you interested to work with us in an international and multi-cultural team? If you like to look beyond your own country, then this position might interest you!
Job description
We are looking for a Regulatory Affairs professional to join the EMEA Regulatory Management Centre, a virtual team of enthusiastic, international colleagues. This position is in the EUCP Labeling Excellence team where the focus is primarily on the centralized approved products. You will work closely together with both regional and local colleagues to ensure high quality and timely submissions to the Health Authorities.
Key Responsibilities:
- Obtaining the information from the EMEA TA on the upcoming EU procedures resulting in EUPI modifications
- Co-ordination of translation activities of English source document in collaboration with translation vendor (central or local), ERMC team and LOCs.
- Ensuring the accuracy of the translated Product Information Annexes of Marketing Authorization against the reference English document in compliance with EU, reference country and /or local legislations.
- Performing and/or co-ordination of Quality Check (QC) of local PI in cooperation with external vendor and LOCs.
- Maintaining the compliance of local translated EU PIs in the Company validated repository system.
- Communicate efficiently with other ERMC sub-teams, LOCs and EMEA TA in scope throughout the process.
- Support in maintaining marketing authorizations.