Associate Director, Global Labeling Strategy Lead

vor 3 Wochen

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 position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert for Sobi products. The incumbent provides strategic and operational leadership on product labeling in collaboration with the Global Regulatory Leads (GRLs) and other stakeholders for assigned products. The Global Labeling Lead (GLL) provides labeling expertise as a core member of the Global Regulatory Team (GRT) for assigned products The GLL leads the content development and maintenance of the company Core Data Sheet (CDS), USPI and EU SmPC, and manages the review of country labeling deviations for assigned products. This includes ensuring compliance with applicable Health Authority (HA) regulations and guidelines, internal company procedures, company core position and business objectives. The GLL is responsible for leading the Labeling Working Group (LWG), for documenting and archiving the outcome of the LWG meetings and communicating and/or escalating these outcomes to the Executive Labeling Committee (ELC) where required. The position will have labeling expertise and serves as a GLL to achieve high quality and accurate labelling in support of business objectives.

**Key Responsibilities**
- As the LWG lead, develop, implement, and maintain the CDS, USPI and EU SmPC for Sobi products throughout their lifecycle. Collaborate with partner companies, where applicable
- Lead cross functional LWGs through all labeling discussions with the FDA/CHMP, while ensuring management alignment and appropriate labeling governance
- Act as point of contact for cross-functional teams on GRA labeling matters
- Collaborate with Regulatory leads for the development of the CDS, EU SmPC and USPI
- Collaborate with local/regional RA for the development of local labels for first submission outside of EU and the US, ensuring alignment to the CDS
- Ensure LWG review of deviations as assessed by local/regional RA and document outcome
- Have an oversight on the compliance status for the end-to-end tracking of safety variations for the assigned products
- Ensure tracking of labeling projects via defined procedures and systems
- Collaborate with Global Labeling Operations as applicable
- Support the development of Standard Operating Procedures (SOPs) and process improvements
- Build cross-functional and cross-regional relationships
- Provide support during inspections and audits

**Qualifications**
- Degree (Bachelor, Master, State Examination, Diploma) preferably in a scientific field, 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 Organizations or at an EU Regulatory Authority with at least 5 years of experience in Regulatory Affairs, including CDS and EU/US Labeling experience
- Experience in a global cross functional environment
- Ability to plan, coordinate and lead activities simultaneously on multiple projects
- Thriving to work in a multi-country, hybrid working environment
- 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
- Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
- Demonstrate excellent communication skills (oral/written/listening) in English
- Solution and detail-oriented; well-organized and self-motivated
- Resilient and flexible to adapt to new situations

**Personal attributes**

In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**

The position will be based Flexible Basel/Stockholm

**Why Join Us?**

We are a global company with around 1,500 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 because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare

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