Johnson & Johnson Careers

Regulatory Affairs Therapeutic Area Expert

Warsaw, Poland
Regulatory Affairs


Job Description

Requisition ID: 1805687623W

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.  Please visit www.janssen.com for more information.
 
Janssen, part of Johnson & Johnson Family of Companies is now looking for:
 
Regulatory Affairs Therapeutic Area Expert
Located in Warszawa
Full-time contract
 
Key responsibilities:
  • Dedicated to respective Therapeutic Areas covering both products under development as well as authorized medicines
  • Partners with local commercial stakeholders with regards to regulatory activities for products in the assigned portfolio
  • Translates RA environment developments into relevant actions for the cross functional Country Value Team (CVT), regional and local RA
  • Supports RA Head in shaping the RA environment through functional and local Trade Associations’ initiatives
  • Monitors the implementation of RA procedures
  • Contacts with Health Authorities
 
Accountabilities:
  • Performs all required product RA tasks, following the plan and updates from the regional teams, enabling optimal label implementation and maintenance, contributing to CVT activities and local strategy optimization with the up to date RA input
  • Ensures that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to corporate RA, to ensure that the company RA strategy can be implemented smoothly
  • Ensures that regional RA receives local RA competitive intelligence with cross-country relevance as well as to make sure CVT gets all relevant competitive intelligence along with its interpretation / impact to enable strategic decisions
  • Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business

Qualifications
  • Educated to University Degree in bioscience, chemistry, pharmacy or in related science field
  • Direct experience and knowledge of regulatory requirements and regulations including labeling requirements in detail
  • Knowledge, understanding and ability to interpret the legislation
  • Regulatory Affairs experience (min. 5+years) including full product RA responsibility
  • Experience in working in pharmaceutical sector with Rx products
  • Experience in multinational pharma company would be an asset
  • Fluent Polish and English, verbal and written
  • High attention to details and analytical skills (e.g. systems, documentation, metrics)
  • Result driven
  • Awareness and ability to understand the broader picture on compliance and launch time
  • Ability to work in a matrix organization
  • Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
  • Flexible, able to work under time pressure and prioritize accordingly
  • Strong interpersonal and communication skills; able to influence without authority.
  • Open for changes and self-development
  • Constructive team player
  • Knowledge of relevant IT-systems (document management, planning, databases); knowing TrackWise, InSight would be an advantage
 
We offer:
  • An opportunity to be part of a global market leading company
  • A dynamic and inspiring working environment
  • Many opportunities to work on challenging projects and assignments
  • Possibilities for further personal as well as professional development
  • Motivating financial remuneration
  • Numerous employee benefits

Primary Location
Poland-Mazowieckie-Warsaw
Organization
Janssen-Cilag Polska Sp. z o.o. (7824)
Job Function
Regulatory Affairs
Requisition ID
1805687623W