Descrição
About Johnson & Johnson:
Johnson & Johnson is recruiting for an EMEA RMC Translation Management Associate in Egypt.
The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs (RA) team responsible for operational regulatory activities, acting on behalf of Local Operating Companies (LOCs). This virtual team is embedded in the EMEA RA organization with team members based in multiple countries across the EMEA region.
Key Responsibilities:
- Coordination of Translation in compliance with JnJ SOP and HA requirements, in collaboration with external and internal partners;
- Performing and/or co-ordination of Quality Check (QC) of local PI in collaboration with external vendors, LOCs, and Medical Affairs as applicable
- Maintaining the compliance of labeling documents of the pharmaceutical products in the validated repository system.
- Being in touch and effectively communicating with other ERMC sub-teams, LOCs, and EMEA TAs in scope throughout the process
- Collaboration with the EMEA RMC Compliance team (e.g. Implementation of the new GRA compliance initiatives).
Qualifications:
Qualifications:
Education:
- A Bachelor's degree in a scientific or equivalent field or a Master’s degree is preferred.
Experience and Skills:
Required:
- Good understanding of the pharmaceutical industry; regulatory experience in drug development and/or maintenance of marketed products
- Expert in detailed labeling work, with a specialized focus on regional and global submission requirements
- Ability to quickly acquire country-specific knowledge and shift between different local situations
- Experience in working in a virtual environment
Preferred:
- Knowledge of quality and supply chain and potential impact on regulatory procedures and status of products
- Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products
Other:
- Ability to communicate fluently in English (including business and RA technical English)
- Intercultural sensitivity to enable smooth collaboration with colleagues across EMEA
- Identify and act on process optimization opportunities.
- Defines operational priorities and tactics.
- Resolves conflict in alignment with the line manager.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.