ERMC Translation Management Associate

About Johnson & JohnsonAt 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 where 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/.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 ResponsibilitiesCoordination 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 applicableMaintaining 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 processCollaboration with the EMEA RMC Compliance team (e.g. Implementation of the new GRA compliance initiatives).QualificationsEducationA Bachelor's degree in a scientific or equivalent field or a Master's degree is preferred.Experience and Skills:RequiredGood understanding of the pharmaceutical industry; regulatory experience in drug development and/or maintenance of marketed productsDetailed knowledge of local regulations and guidance s in the cluster/region related to the full drug life cycle; understanding of how these apply to specific projects and how to interpret them in the context of the scientific and commercial environmentExpert in detailed labeling work, with a specialized focus on regional and global submission requirementsAbility to quickly acquire country-specific knowledge and shift between different local situationsExperience in working in a virtual environmentPreferred:Knowledge of quality and supply chain and potential impact on regulatory procedures and status of productsAwareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific productsOther:Ability to communicate fluently in English (including business and RA technical English)Intercultural sensitivity to enable smooth collaboration with colleagues across EMEAIdentify 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.For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.