Johnson & Johnson, through its operating companies, is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Junior Regulatory Affairs Manager (M/F/D)
(Ref: 2105969914W)
Location : Zug
Permanent Contract : 100%
Are you passionate about crafting a world without disease? Do you have expertise in Regulatory Affairs Switzerland? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science, and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science.
Janssen Cilag is currently recruiting a talented Junior Regulatory Affairs Manager located in Zug, Switzerland to lead accelerated broad patient access from regulatory perspective for Janssen’s key brands. The successful candidate will act as the local regulatory specialist on the designated products. The jobholder will report into the Lead Regulatory Affairs, who in turn reports into the Director External Affairs & Market Access.
YOUR responsibilities & YOUR impact:
- Life-cycle management of existing registration licenses, including submissions of line extensions, labeling and CMC variations, renewals, PSUR, etc.
- Liaising and closely collaborating proactively with the cross functional team including Quality Assurance, Supply and Market Access
- Enabling timely approvals with advantageous wording in the product information as supported by clinical and scientific data and in accordance with regulatory guidelines and business needs
- Providing most accurate pipeline planning
- Securing dispatch of Global dossiers within the assumed business plan timeline and ensuring preparation of a commercial business case if relevant
- Communicating to Global teams the Swiss specific regulatory processes and requirements
- Acting as reliable and competent contact to Swissmedic for the assigned products
- Monitoring legal requirements for registration processes
- Publication process of the drug information including proofreading with responsibility for timely and correct publication
- Ensure efficient compliance to local, regional and Janssen regulations, to minimize risk for the patients and Janssen business
Qualifications
We would love to hear from YOU, if you have:
- Pharmaceutical or scientific university degree
- Experience of 1 to 2 years in Regulatory affairs working with Swissmedic within the pharmaceutical industry
- Reliable, positive, energized, and self-motivating personality, teamplayer
- Strong communication and presentation skills with the ability to convert complex data in simple messages, diplomacy, and interpersonal adaptability
- Fluency in German and English, French and Italian is a plus
This is what awaits YOU at J&J:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees benefits.
Primary Location
Switzerland-Zug-Zug-
Organization
Janssen-Cilag Switzerland (7325)
Job Function
Regulatory Affairs
Requisition ID
2105969914W