Manager Regulatory Affairs Process, Data, Compliance EMEA Oeiras

Manager Regulatory Affairs Process, Data, Compliance EMEA
Oeiras
Oeiras, Distrito de Lisboa, Portugal

Manager Regulatory Affairs Process, Data, Compliance EMEA

Join to apply for the Manager Regulatory Affairs Process, Data, Compliance EMEA role at Johnson & Johnson Innovative Medicine

Manager Regulatory Affairs Process, Data, Compliance EMEA

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Join to apply for the Manager Regulatory Affairs Process, Data, Compliance EMEA role at Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and Med
Tech, 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

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Madrid, Spain, Novi Beograd, Beograd, Serbia, Porto Salvo, Portugal, Warsaw, Masovian, Poland

Job Description

Regional Regulatory Affairs at Johnson & Johnson Innovative Medicines is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance with focus on EU.

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 role partners closely with regional and Local Operating Company (LOC) RA teams, as well as with
- regional and global partners in the GRA organization, to deliver sustainable solutions and support stakeholder needs. This role will also connect with relevant
- functional partners, e. g. Commercial Quality and Medical Safety for
- functional alignment on process, data and compliance topics.

This role is a member of the
- regional Regulatory Affairs Process Support, Data Integrity and Compliance team and a catalyst to the team's success.

Key Responsibilities

Regulatory Affairs Process Support

• 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.
  
  

• 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.
  
  

• Ensure the appropriate level of compliance in the RA EMEA Strategy Organisation
• Coordinate contributions from EMEA RA TA teams to audits and inspections, as needed
• Coordinate assessment and implementation of new/revised EU regulatory requirements with RA impact
• Advise EMEA RA TA teams on identification and management of
  - conformances, CAPAs, quality or compliance issues.
  
  

• At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including activities in a regulatory compliance or Gx
  P 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
  - functional stakeholders on global, regional and local level
• Excellent
  - cultural interpersonal and influencing skills
• Ability to communicate effectively in English, verbally and in writing
• Flexibility and proactivity
• Team-player
  
  

• This position is based in Europe (primarily Poland, Portugal, Serbia or Spain, consideration can be given to candidates in other European locations)
• Reachable during Europe office hours and outside office hours in case of emergencies
• Flexibility for limited travel within Europe (~5%)

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

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