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J&J Family of Companies Regulatory Affairs Professional in Prague, Czech Republic

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 business every day. Our dedication to respecting the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where a diverse set of backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Janssen-Cilag Czech Republic is recruiting for a Regulatory Affairs Professional, located in Prague.

Under the supervision of the Head of Regulatory Affairs, the Regulatory Affairs Professional (RAP) is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:

Support in acquiring and maintaining marketing authorizations.

Contribute to fast introduction of new products and line extensions including new indications.

Ensure regulatory compliance with local and EU legislative and internal procedures.

Key Responsibilities: RA department

  • Handling incoming and outgoing correspondences, including archiving.

  • Maintain the local product files in line with currently registered authorization details according to the relevant local and EU legislation.

    New and existing products

  • Prepare and submit regulatory submissions with support from regulatory operations.

  • Ensure deadlines for different projects are met or escalated to the Head of RA.

  • Participate in internal working groups as required and address any regulatory actions with senior RA colleagues.

  • Maintain the product label and packaging in line with current registered authorization details according to the relevant local and EU legislation including related electronic systems and tracking activities.

    Compliance

  • Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems …).

  • Maintain an awareness of regulatory guidelines/directives/national requirements.

    Internal contacts

  • Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales).

  • Support tender business.

    External contacts

  • Communication with the local health authority, in general, and on product-specific topics in case of need.

    Miscellaneous

  • Support and contribute to GRA-EMEA initiatives.

Qualifications

  • Completed university education, preferably natural sciences (pharmacy, biology, chemistry, medicine)

  • Previous experience in Regulatory Affairs at least 3 years

  • Fluent in Czech

  • Strong knowledge of English, both verbal and written

  • Knowledge of MS Office

  • Ability to work independently

  • Ability to work precisely, without errors of a formal and factual nature, and systemically

  • Ability and willingness to work hard, multitasking

  • Flexibility and willingness to learn new things

  • Stress resistance

  • Ability to tackle problems

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 an accommodation.

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.

Primary Location

Czech Republic-Prague-Prague-

Organization

Janssen-Cilag .s.r.o (8397)

Job Function

Regulatory Affairs

Requisition ID

2105987430W

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