J&J Family of Companies Senior Manager Regulatory Affairs Diagnostics in Beerse, Netherlands
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
Janssen provides an opportunity to work in a highly innovative, new and growing personalized medicines business in the Johnson & Johnson Pharmaceutical Sector. This senior level position reports in the Janssen Global Regulatory Affairs organization. The function supports regulatory activities for companion diagnostics, mobile apps and wearable devices to Janssen drugs in Europe, Middle East and Africa (EMEA). The working location is Beerse, Belgium
Responsibilities & Accountabilities
Support the Therapeutic Regulatory Leader, Global Regulatory Leader and/or Application Owner for regulatory activities for In Vitro Diagnostics (IVD), Software as a Medical Device or Wearable Devices in development and/or marketed pharmaceutical products. Provide guidance and support to project teams regarding regulatory compliance issues.
Prepare or review regulatory strategies and plans.
Create or coordinate STED submission files and design dossiers for EMEA. This might involve managing contractors or interacting with external development parties.
Interact with notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
Manage external standards, including the monitoring of changed/new regulations, guidelines and standards, coordinating the review with the subject matter expert, manage the external standards database.
Create and submit US State License renewal and extension files for the Janssen Diagnostic Clinical Laboratory in Beerse. Follow up with the US State health authorities for a smooth continuation of the lab licenses.
Perform copy review of promotional and scientific material to verify compliance with the approved claims.
Evaluate regulatory impact of product changes.
Education & Experience
Bachelors, preferably Masters, degree in biochemistry, microbiology, pharmacy or life-science or health-related discipline with minimum 10 years business experience.
Minimum 5 years experience with regulatory strategies and EU conformity assessments for In Vitro Diagnostics (IVD Dir 98/79/EC), preferably for molecular diagnostic assays, and/or Medical Devices (Dir 93/42/EEC).
Proficient use of digital technology.
Working language is Dutch and English; mastering other major European languages is an asset.
Collaborative team-player with a dynamic personality.
Excellent verbal and written communication skills.
Detail oriented regulatory leader.
Ability to take charge and follow-through with minimal supervision.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)