Emea Regulatory Management Center Translation LATINA

Emea Regulatory Management Center Translation
Latina
Lazio, LATINA

At **Janssen**, we're creating a future where disease is a thing of the past.

We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We have 40, 000 people around the world who show up every day to achieve the unimaginable.

This work requires heart, science, and ingenuity.

We never stop imagining a future where the most challenging diseases are a thing of the past.

For our** EMEA Regulatory Management Center (RMC)** we a re looking for a responsible of **Translation Management** to hire with a **permanent contract**.

The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for majority of the operational regulatory maintenance activities, acting on behalf of Local Operating Companies (LOCs) and led by senior regulatory staff.

ERMC handles tactical Life Cycle Management (LCM) processes like CMC variations and Labeling changes in the region.

The ERMC is a virtual team reporting directly to ERMC management and is located in the EMEA countries working mostly in the LOCs.

The responsibility of the ERMC Translation Management is:

- to support a large, diverse and complex geographic EMEA region

- to work on assigned product RA life cycle management procedures together with ERMC EUCP Translation Management, ERMC Translation Management, ERMC Data Management & Compliance, ERMC Planning, ERMC Life Cycle Management, ERMC Artwork Management, EMEA liaisons, other respective GRA stakeholders and LOC RA respective staff.

- to coordinate labeling translation

- maintaining high quality of the Labeling document in compliance with JnJ SOP and HA requirements.

- Co-ordination of translation activities of English source text (e. g.

EU Product Information (EUPI)) in cooperation with external 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 PI and English back-translation in the Company validated repository system

- Being in touch and effectively communicate with other ERMC sub-teams, LOCs and EMEA TA in scope throughout the process

- Ensuring implementation of standardization/new systems and processes to ensure efficiency gains and to support business continuity

- Contribution to fast introduction of new products and line extensions including new indications

- Support in maintaining marketing authorizations

- Contribution to other labeling projects/assignments, as appropriate

- Collaboration with EMEA RMC Compliance team (eg.

Implementation of the new GRA compliance initiatives)

- Supporting the management of events and deviations related to Translation Management process

- Participate in audit-readiness activities

- Participates in other tasks assigned by ERMC Translation Management sub-team Lead and ERMC Head

The ERMC Translation Management has a direct reporting line to the ERMC Translation Management sub-team Lead.

**Qualifications

- A minimum of a University degree or equivalent by experience

- At least 2 years of regulatory affairs experience

- In depth knowledge of (eg.

local and regional regulations/legislation)

- Experience in regulatory (eg.

translations Life Cycle Management and in co-operation with HAs)

- The following experience is seen as an advantage:

- Working in a virtual environment

- Experience in a regional/global organisation

- 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 spoken English

- 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

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 and will not be discriminated against on the basis of diversity.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do