Regulatory Affairs Manager

Vor 2 Tagen

Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

Janssen-Cilag AG is looking for a Regulatory Affairs Manager (M/F) based in Zug.

**Company Background & Culture**:
Caring for the world, one person at a time inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products, and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.

**Who is Janssen?**
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.

**Role Purpose**:
**Key responsibilities include**:

- Leading complex regulatory projects and securing an as quick as possible registration of new products and indications with the best possible outcome
- Maintaining the existing registration licenses through development and executing of a regulatory strategy for each assigned regulatory drug project
- Handling the entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, 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 is supported by clinical and scientific data and in accordance with regulatory guidelines and business needs
- Providing the most accurate pipeline planning
- Securing dispatch of Global dossiers within the assumed business plan timeline and ensuring preparation of a commercial case if relevant
- Communicating to Global teams the Swiss specific regulatory processes and requirements
- Acting as a reliable and competent contact to Swissmedic for the assigned products
- Monitoring legal requirements for registration processes
- Ensure efficient compliance to local, regional, and Janssen regulations, to minimize risk for the patients and Janssen business

**Qualifications**
- Pharmaceutical or scientific university degree
- Significant experience (~3-5 years) in Regulatory affairs working with Swissmedic within the pharmaceutical industry and a proven track record of outstanding approvals
- Experience in working in Quality assurance or Market Access is a plus
- Reliable, positive, energized, and self-motivating personality, teammate
- Strong communication and presentation skills with the ability to convert complex data into simple messages, diplomacy, and interpersonal adaptability
- Ability to adapt communication style based on audience and situation
- Fluency in German and English, French and Italian is a plus

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location**
Switzerland-Zug-Zug
- **Organization**
Janssen-Cilag Switzerland (7325)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206007764W

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