Head of Global Labeling Strategy

vor 2 Monaten

Basel, Schweiz Sobi Vollzeit

**Company Description**
**_

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

This position leads the Global Labeling strategy team at Sobi and provide strategic directions on global labeling issues. In addition, the Artwork management team at IQVIA has a dotted line to this role. The Head of Global Labeling has the role as Global Process Owner with responsibility for the labeling process and governance.

**Key Responsibilities/Scope of the Job**

Including, but not limited to the following:

- Provide oversight of product labeling at Sobi
- Promotes partnerships with project/program teams to ensure key submission milestones are met
- Sets functional goals which contribute to the departments vision and long-range planning
- Leads a team of Global Labeling leads and Labeling Co-ordinator
- Provides line management to direct reports including training, performance management, professional development and coaching
- Provides excellent understanding of labeling requirements and guidance
- Manages Sobi Executive Labeling Committee (ELC) and is responsible for follow-up on ELC decisions regarding labeling
- Ensures that product labeling reflects a complete and accurate description of the risks and benefits of Sobi products based on available data
- Ensures timely creation and updates of CDS that represent Sobi’s position on maximum efficacy and core safety of Sobi’s products and approval of CDS deviations
- Provides oversight of labeling operations work including artwork and mock-up creation and updates
- Makes decisions on administrative and operational matters and ensures the labeling team effectively achieves its objectives
- Utilize strategic thinking and risk assessment capabilities in your area of responsibility
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and best practices
- Contribute to the development and maintenance of Regulatory Affairs working practices & procedures
- Additional duties may be assigned, as needed

**Qualifications**
Education/Learning Experience/Work Experience
- A University Degree in Life Sciences is required with 10 years of industry experience of which at least 8 years of experience within Regulatory Affairs in a Labeling role and at least 5 years of formal people management
- Diverse experience working with a variety of pharmaceutical products
- Extensive experience working with regulatory labeling for Prescription medicines and interacting with Regulatory Agencies including the US FDA on labeling issues
- Experience leading and managing updates to prescribing information
- Extensive experience working in a global environment
- Experience of leading projects and cross-functional teams

Skills/Knowledge/Languages
- Extensive knowledge of Labeling regulations and guidance
- Thorough knowledge of the drug development process, with a focus on IND and NDA processes
- 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

**Personal Attributes**
- 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

**Additional Information**
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

**Why Join Us?**

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives beca

  • Associate Director, Global Labeling Strategy Lead

    vor 7 Monaten

    Basel, Schweiz Sobi Vollzeit

    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...

  • Head of Global Regulatory Strategy, Immunology

    vor 1 Woche

    Basel, Schweiz Sobi Vollzeit

    **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.** **Head of Global...

  • Global Head of Quality Strategy, Consumer Health

    vor 6 Monaten

    Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Global Director of Strategy Biopharmaceuticals

    vor 22 Stunden

    Basel, Schweiz Sandoz Vollzeit

    100% revenue growth, that is our ambition for the Biopharmaceuticals business unit for the next 5 years. To broaden access to affordable biologics for patients, this is our purpose at Sandoz Biopharmaceuticals. - Sandoz, a division of Novartis, is a global leader in Generic and Biosimilar medicines. We are committed to building on that leadership to drive...

  • Global Head of Pricing

    vor 3 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **_OBJECTIVES/PURPOSE:_** The **Global Head of Pricing** is a pivotal role that develops and executes Abbott’s global pricing strategy, guidance, governance and processes to fulfill our purpose Life. To The Fullest. The Head of Pricing will partner with the respective regional access teams, Global Access team, Policy, Government Affairs, Finance and HEOR...

  • Global Head of Tender Management

    vor 7 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **Abbott** is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Global Head of Tender Management

    vor 2 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Abbott...

  • Head of M&a Tax

    Vor 5 Tagen

    Basel, Schweiz Novartis Vollzeit

    The Head of M&A Tax is the accountable Tax lead for all Novartis group transactions (such as BD&L; NTO in-vestments/divestments; M&A) including the treasury advice on tax efficient structuring of transactions. In close collaboration with business stakeholders the Head of M&A Tax is responsible to deliver the tax strategy on deal process optimization,...

  • Global & Emea Strategy Manager

    Vor 4 Tagen

    Basel, Schweiz Deutsche Bank Vollzeit

    The Strategy team for our IPB businesses leads the formulation, execution and communication of the strategic direction and supports the regional leadership team in this respect for the global IPB business. The team plays a crucial role in business development activities, partners with other areas of IPB to ensure effective strategy execution and provides...

  • Head of Innovation, Strategy and Marketing

    vor 7 Monaten

    Basel, Schweiz Batterman Consulting Basel AG Vollzeit

    **Unser Kunde** Unser Kunde ist ein international tätiges Schweizer Maschinenbau-Unternehmen mit rund 130 Mitarbeitenden. Das Unternehmen ist seit 60 Jahren führend in der Herstellung von Prozessanlagen. Die verfahrenstechnischen Anlagen und Sondermaschinen, werden weltweit in der Chemie-, Prozess - und Lebensmittelindustrie eingesetzt. Des Weiteren...

  • Global Head of Merchandising, Footwear

    vor 7 Monaten

    Basel, Schweiz On AG Vollzeit

    **In short**: As Global Head of Merchandising for our footwear categories you will be responsible for ensuring the right products go to the right channels, tiers and accounts and to the right store, with the best timing and price, to optimize our brand vision and the selling and profitability. You will secure the assortment across footwear, linked to apparel...

  • Strategy Director, Clinical Development

    vor 6 Monaten

    Basel, Schweiz Novartis Vollzeit

    395319BR **Strategy Director, Clinical Development**: Switzerland **About the role** The purpose of this role will be to support the crafting and execution of portfolio strategy and clinical prograM/Functional excellence by actively partnering with the Head of Portfolio Strategy and Operations, Clinical Development Functional Heads, Head of Clinical...

  • Global Program Safety Lead

    vor 7 Monaten

    Basel, Schweiz Novartis Vollzeit

    391327BR **Global Program Safety Lead - Immunology**: Switzerland **About the role** The GPSL ensures optimal patient safety and leads the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management. This position reports to the Head Patient Safety Immunology. **Key...

  • Manager, International Artwork and Labeling

    vor 1 Woche

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Director of Printed Packaging Materials, the Manager, International Artwork & Labeling is a newly created position responsible for artwork and labeling change activities within the Global Commercial Supply Chain. The individual will have ownership of international artwork and labeling changes for Moderna’s commercial...

  • Eu Regulatory Strategy Lead Hemophilia

    Vor 7 Tagen

    Basel, Schweiz Sobi Vollzeit

    **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.** **EU Regulatory Strategy...

  • Deputy Head of The Innovation Hub and Head of

    vor 6 Monaten

    Basel, Schweiz Bank For International Settlements Vollzeit

    **Deputy Head of the Innovation Hub and Head of Strategy and Operations, Bank for International Settlements** The BIS supports central banks’ pursuit of monetary and financial stability through international cooperation and serves as a bank for central banks. The mission of Bank for International Settlements Innovation Hub (BISIH) is to foster...

  • Head of Services

    vor 3 Monaten

    Basel, Schweiz Fachportal Kulturen und Gesellschaften Vollzeit

    Head of Services, Swiss Tropical and Public Health Institute (Swiss TPH), Basel14.10.2024Head of ServicesSwiss Tropical and Public Health Institute (Swiss TPH), BaselStart date: 1 March 2025 (or upon earliest availability)The Swiss Tropical and Public Health Institute (Swiss TPH) is a world-leading institute in global health with a particular focus on low-...

  • Global Head of Operations Transformation

    vor 7 Monaten

    Basel, Schweiz Straumann Group Vollzeit

    **Job Purpose**: The Head of Global Operations Transformation leads her/his organization to support the Operations Lead team in implementing our prOPulSe transformation along its 8 pillars: #1 reducing COGS, #2. establishing a customer obsessed E2E SC, #3 increasing our competitive advantage through Quality and Regulatory affairs, #4 building capacity to...

  • Global Head of Talent

    Vor 7 Tagen

    Basel, Schweiz Straumann Group Vollzeit

    The Straumann Group business is transforming, and we strive to become the most customer centric company in oral health care. Our approach to talent is becoming a key strategic focus as we connect internal talent with career and growth opportunities enabling our future. The Head of Talent is a new role at Straumann Group acting as a thought leader, driving...

  • Head of Patient Safety

    vor 1 Woche

    Basel, Schweiz Source Group International Vollzeit

    Xplore Life Sciences are recruiting for a **Head of Patient Safety **to work for a global leader in Pharmaceuticals based in Basel Switzerland. You must be able to work on site in Basel for at least 2-3 days a week. **Only EU/EFTA Citizens or those who possess a valid Swiss work permit will be eligible for this role** **Major Accountabilities**: -...