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We are looking for a new member in our EMEA Regulatory Affairs (RA) Data Team, which is responsible for entry of pharmaceutical Marketing Authorisation tracking data into our global systems, on behalf of the data owners (local operating company and regional teams across Europe, Middle East, Africa).

Our EMEA RA Data Team currently consists of approximately 15 RA Professionals and two team leads and works fully virtually with members based in our local offices across the region.

The position is a temporary contract position of 9 months.
Essential Job Duties and Responsibilities

Enter and maintain accurate and timely marketing authorisation related data in the assigned systems on behalf of data owners.

• Regulatory Affairs data entry activities
• Track incoming data entry requests and follow up until completion in alignment with global and regional data quality standards and procedures
• Enter data in the relevant systems based on information provided by data owners
• Scrutinize provided data with data owners and instruct data owners as needed, to ensure consistency and quality of data in the relevant systems
• Ensure data owner alignment with data entered in the relevant systems on their behalf
• Ad hoc activities
• Support data owners with guidance, training, instructions on the process and requirements for maintaining data in the relevant systems
• Provide ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations
• Coordinate and/or perform other data management acitivites upon request, e.g.
• data verification with data owners
• data monitoring and follow up with data owners
• data analysis and data cleansing
• Contribute to process development and process improvement activities in EMEA and globally as needed
• Align with supervisor and team members to ensure data entry backup capabilities during vacation and holiday periods
• Perform other related tasks as assigned by supervisor
• Maintain compliance with all company policies and procedures.

Minimum Qualification

• Good understanding of pharmaceutical Marketing Authorisation data and regulatory procedures (national as well as EU procedures)
• Understanding of regulatory data planning and tracking requirements
• Knowledge of compliance requirements and advanced process thinking
• Good technical skills and computer proficiency
• Proven ability to monitor multiple actions and timelines and follow up until timely completion
• Ability to work effectively in a matrix organisation with multiple cross-functional collaborators on global, regional and local level
• Excellent cross-cultural communication skills in English
• Flexibility and proactivity
• Team-player

Other requirements

• Flexibility for limited travel

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.