Johnson & Johnson Careers

Regulatory Affairs Specialist

Warsaw, Poland
Regulatory Affairs


Job Description

Requisition ID: 1805691048W

The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.

Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.

 

REGULATORY AFFAIRS SPECIALIST  

Location: Warsaw

Full time 1-year contract


Role Overview:

 

Coordination, compilation, and submitting of relevant applications to the regulatory agencies (medicinal products, medical devices, cosmetics). Ensuring respective registration/notification objectives are met & ensuring full compliance with local and EU requirements towards RA activities. Effective cooperation with Marketing/CatSol/Supply teams/QA to meet annual targets and objectives.   

 

Main responsibilities:

 

  • Under supervision, prepares and compiles routine regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines for internal review / approval
  • Follow up whether company's documentation of JnJ products is in compliance with requirements, implementation of any approved changes and communicating them to relevant stakeholders
  • Under guidance, interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters
  • Works under supervision to plan, conduct, and manage regulatory activities to meet department and company objectives
  • Develops, translates (if relevant) and reviews artworks and product information to ensure regulatory compliance
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
  • Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Provides solutions to a variety of problems of moderate scope and complexity
  • Archiving of all documents and correspondence submitted to and received from the Authority according to the globally and locally agreed processes
  • Updates relevant global, regional and local databases to ensure compliance
  • Under guidance, inputs to regulatory strategies
  • Under supervision, communicates information and presents status updates on product/project activities to key internal /external stakeholders
  • Organizes and maintains reporting schedules
  • Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties
  • Conducts searches of existing files for requested information


Qualifications

Qualifications:

  • University/bachelor’s degree or equivalent
  • 1 - 3 years’ experience in regulatory affairs
  • Good knowledge and experience in regulatory tasks for medicines
  • Understanding of cosmetic market and medical devices legislation would be advantage
  • Fluent command of English and native level Polish is a must - both written and spoken

We Offer:

  • An opportunity to be part of a global market leader
  • A dynamic and inspiring working environment
  • Possibilities for further personal as well as professional development
  • Work in a positive atmosphere with a highly motivated, energized team a good track level of success in business
  • Many employee benefits 

If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English via MyCareerOpportunities.net, EmployeeReferrals.jnj.com or via careers.jnj.com



Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Regulatory Affairs
Requisition ID
1805691048W