Johnson & Johnson Careers

Head of Regulatory Affairs

Prague, Czech Republic
Regulatory Affairs


Job Description

Requisition ID: 1905720679W

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 an experienced Head of Regulatory Affairs:
 
Head of Regulatory Affairs
Full-time permanent contract
 
Role Overview:
Management of the RA at the Local Operating Company. Contribute to obtaining and maintaining marketing authorizations. Contribute to local commercial strategies with regulatory strategic input. Ensure fast introduction of new products and line extensions including new indications. Maintain and support communications with Health Authorities and third parties. Ensure regulatory compliance. Streamline regulatory activities with other internal business partners. Influence regulation environment through external stakeholders.
 
As Head of Regulatory Affairs, you will have the following areas of responsibility:
  • Departmental management
    • Manage goals and objectives of the RA department in line with RA-EMEA & business goals and objectives
    • Planning, prioritization and resources management of regulatory activities in line with objectives
    • People management, including coaching, training, development, performance review etc.
    • Represent RA at Senior management level
    • Ensure implementation of standardization/new systems and processes to ensure efficiency gains and to support business continuity
       
  • New and existing products
    • Ensure preparation and submission of quality regulatory submissions with support from regulatory operations
    • Ensure deadlines for different projects are met or escalated to relevant higher management
       
  • Compliance
    • Ensure 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)
    • Keep abreast of the changes in regulatory legislation/guidelines and assess the impact on the company
    • Provide consultation, interpretation and advice to other relevant group in order to ensure compliance with regulatory guidelines/directives/national requirements
       
  • Contact with key stakeholders
    • Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales)
    • Support tender business
    • Build and sustain positive relationships with the local health authorities, in general and on product specific topics
    • Represent the company in regulatory industry associations in order to positively influence the regulatory environment
  • Miscellaneous
    • Support and contribute to GRA-EMEA initiatives
    • Monitor HA website for any news concerning regulatory environment in CZ on daily basis

Qualifications
Qualifications and experience of the successful candidate:
  • University Degree in Pharmacy, Biology, Chemistry or related Life Science
  • Extensive Regulatory Affairs experience (8+years) at both operational and strategic level
  • Direct experience and strong knowledge of local/regional regulatory requirements and guidelines Fluent in relevant local language and English
  • Ability to manage multiple tasks, projects, priorities and complex systems simultaneously
  • Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams
  • Ability to work under strict timelines, combined with flexibility when emergency situations require this
  • Project management skills
  • People management skills are advantage
  • Full competency in local languages and an appropriate knowledge of English
 
In return, 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.

Primary Location
Czech Republic-Prague-Prague-
Organization
Johnson & Johnson Slovakia, spol. s.r.o (7067)
Job Function
Regulatory Affairs
Requisition ID
1905720679W