Regulatory Affairs Manager

3 dni temu

Warszawa, Mazovia, Polska Johnson & Johnson Pełny etat

About 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.

As a leading healthcare company, we have a unique opportunity to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow, and profoundly impact health for humanity.

This role provides regional leadership to the Regulatory Affairs (RA) EMEA Strategy Organisation in the areas of RA process support, data integrity and compliance.

The successful candidate will partner closely with regional and Local Operating Company (LOC) RA teams, as well as with cross-regional and global partners in the GRA organisation, to deliver sustainable solutions and support stakeholder needs.

Main Responsibilities:

  • Provide strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes, including interpretation of regulatory and procedural requirements.
  • Facilitate input into global/regional processes and procedures impacting EMEA RA TA teams, partnering with assigned Substance Matter Experts (SMEs) as applicable.
  • Ensure, coordinate, develop and/or deliver (as needed) training and communication on RA processes, in collaboration with assigned business process owners and SMEs.
  • Identify and drive process alignment and improvement opportunities across EMEA RA TA teams.
  • Act as the coordinator/owner of assigned EMEA RA TA processes.

Data Integrity and Compliance

  • Ensure robust tracking and maintenance of EU RA data in J&J's and European Medicines Agency's (EMA) systems and tools.
  • Provide guidance, trainings and communication on EU RA data tracking requirements in J&J's and EMA's systems and tools.
  • Coordinate/provide input from an EU perspective on global RA data tracking systems, tools, requirements, projects and processes.
  • Provide support and advice to EMEA RA TA teams on efficient and compliant use of RA data systems and tools.

Key Qualifications:

  • At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including activities in a regulatory compliance or GxP environment.
  • Excellent understanding of pharmaceutical Marketing Authorisation regulatory procedures and digital interactions with Health Authorities in EU/EEA.
  • Understanding of regulatory data planning and tracking processes and systems, including EU requirements.
  • Knowledge of RA compliance requirements and advanced process thinking.
  • Good technical skills and computer proficiency.
  • Proven track record to monitor multiple actions and timelines and follow up until timely completion.
  • Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
  • Excellent cross-cultural interpersonal and influencing skills.
  • Ability to communicate effectively in English, verbally and in writing.
  • Flexibility and proactivity.
  • Team-player.

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