Global Labeling Lead

vor 2 Wochen

Basel, Schweiz Sobi Vollzeit

**Global Labeling Lead**

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

**Role & Function**

This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert for Sobi products. The incumbent provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and other stakeholders for assigned products.The Global Labeling Lead leads the coordination, content development and maintenance of the CCDS, USPI and EU SmPC labeling, and manages the review of country labeling deviations for assigned products. This includes ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures, company core position and company business objectives. The Global Labeling Lead is responsible for documenting and archiving the outcome of the Labeling Working Group meetings and communicating and/or escalating these outcomes to the Executive Labeling Committee where required. In addition, this role manages new projects and projects of increased complexity including those involving 3rd party collaborators. The position will have regional EU labeling expertise and serves as a Global Labeling Lead to achieve high quality and accurate labelling in support of business objectives.

**Key Responsibilities**
- Lead the development of the Company Core Datasheet (EU and US Documentation): As the project lead, manage, develop, prepare and implement regulatory for new products or products in the development phase
- Lead cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed
- Acts as point of contact for cross-functional teams on RA labeling issues
- Collaborate with Regulatory Affairs and Regulatory colleagues in other regions, including Japan, while developing the CCDS
- Ensure Compliance with Core Data Sheets/Label Changes
- Conduct Label Review Committee Meetings: Lead review processes to ensure appropriate review and governance, and where applicable, partner companies for the development and approval of US, EU and global CCDS documents for regulatory filings and HA labeling discussions. Collaborate closely with colleagues in Japan and with country RA
- Demonstrate expert knowledge of global labeling guidance to ensure compliance
- Collaborate with Global Labeling Operations and Compliance leads to provide high quality labeling documentation
- Establishes Process Best Practices: Lead the development of Standard Operating Procedures (SOPs) and process improvements.
- Builds cross-functional and cross-regional relationships

**Qualifications**
- Degree (Bachelor, Master, State Examination, Diploma) preferably in a scientific degree, e.g. in Pharmacy, Medicine, or Life or Natural Sciences; Master, Pharm. D. or PhD preferred
- At least 8 years of working experience in Pharmaceutical Industry, at Clinical Research
- Organizations or at an EU Regulatory Authority with at least 5 years of experience inRegulatory Affairs including CCDS and EU/US Labeling experience.
- Experience with country labeling (outside the US/EU) is a plus
- Experience of working in global environment
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well-organized and self-motivated
- Excellent written and oral communication skills in English, second EU language preferred
- Above-average proficiency with basic technology tools (e.g. MS-Office, etc.).
- Demonstrate excellent communication skills (oral/written/listening) in English. Knowledge of any other languages would be an asset.
- Proven to be able to be analytical, connect the dots and propose a strategy to address challenges and business needs

**Personal Atributes**

Results driven and team-oriented attitude with the ability to influence outcomes. Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously. Proven ability to innovate, especially with analysing & solving problems, with mínimal supervision and exceptionally keen skills for attention to detail. Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.Travel occasionally (domestic and international).In addition, you must demonstrate behaviors in line with Sob

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