Johnson & Johnson Careers

Regulatory Affairs Head and Therapeutic Area Expert

Warsaw, Poland
Regulatory Affairs


Job Description

Requisition ID: 1705615349W

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 experience Regulatory Affairs Head and Therapeutic Area Expert:
 
Regulatory Affairs head and Therapeutic Area Expert
Located in Warszawa
Full-time temporary contract for 12 months
 
Role Overview:
Regulatory Affairs Head is responsible for overall management of the Regulatory Affairs group and all regulatory activities to support and grow the business in line with the company goals. The person has a role of RA External Affairs Lead with responsibility to shape RA external environment and is responsible for part of the portfolio within the role of RA Therapeutic Area Expert.
 
As Regulatory Affairs Head, you will have the following areas of responsibility:
  • Management of the Regulatory Affairs Department
  • People management of the Regulatory Affairs Team
  • Management of the external regulatory environment
  • Contribution to the GRA organization
  • Work with Compliance to implement processes, standards and training that ensure a continuous high regulatory compliance level and a constant status of “inspection readiness”.
  • Dedicated to Therapeutic Areas for development of in-Market and Established products
  • Strong leading influence on main regulatory external stakeholders and regulations, in line with local and regional strategy, maximizing the possibilities of success for market access, reimbursement and lifecycle maintenance of Janssen products
  • All overarching (cross-TA) and strategic discussions with health authorities and trade associations to shape the regulatory environment

Qualifications
Qualifications and experience of the successful candidate:
 
• Big picture view of the regulatory role in the pharmaceutical industry
• Product RA legislation knowledge
• Knowledge, understanding and interpretation of legislation
• Awareness and ability to understand the broader picture on compliance and launch time
• Able to analyze (complex) information and situations and to formulate clear advises
• Very strong interpersonal and communication skills; able to influence without authority.
• Strong project management, problem solving and negotiating skills
• Able to make independent decision
• People management skills
• Apart from a language, very good knowledge of English, verbal and written
• Multitasking, accurate and conscientious
• Knowledge of regulatory IT systems (document management, planning, databases….)
• Educated to University Degree preferably in life science
• Certified Regulatory Affairs knowledge;
 
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
Poland-Mazowieckie-Warsaw
Organization
Janssen-Cilag Polska Sp. z o.o. (7824)
Job Function
Regulatory Affairs
Requisition ID
1705615349W