Manager, Global Labeling Product Leader

**Function**
- Regulatory Affairs Group

**Sub function**
- Regulatory Affairs

**Category**
- Manager, Regulatory Affairs (P7)

**Location**
- Allschwil / Switzerland

**Date posted**
- Jul 01 2025

**Requisition number**
- R-021552

**Work pattern**
- Hybrid Work

Description

**Job Function**:
Regulatory Affairs Group
** Job Sub Function**:
Regulatory Affairs
** Job Category**:
Professional
** All Job Posting Locations**:
Allschwil, Basel-Country, Switzerland
** Job Description**:
About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
- United States - Requisition Number: R-020573
- Belgium - Requisition Number: R-021550
- United Kingdom - Requisition Number R-021551
- Switzerland - Requisition Number: R-021552

Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is a hybrid role and will be located in Allschwil, Switzerland.

The Manager, Global Labeling Product Leader will be responsible for the following:

- Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.
- Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents.
- Contribute to and participate in the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
- Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications:

- A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
- A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
- A minimum of 3 years of Regulatory Affairs experience in product labeling/labeling regulations, or equivalent is preferred.
- An understanding of pharmaceutical drug development is required.
- Experience in discussing and communicating scientific concepts is required.
- Experience leading project teams in a matrix environment is required.
- Experience participating in continuous improvement projects is required.
- Experience working with document management systems is required.
- Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
- Must have exceptional verbal and written communication skills.
- Must have strong organizational, negotiation, and partnering skills.
- Must have the ability to work independently.
- The ability to drive a collaborative, customer-focused, learning culture is preferred.

LI-Hybrid