Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

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.

Our mission and culture at Sobi North America 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
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). 

The incumbent provides strategic and operational leadership on product labeling in collaboration with the Global Regulatory Leads (GRLs) and other stakeholders and serves as a core member of the Global Regulatory Teams (GRT) for assigned products. This includes:

• leading the coordination of content development and maintenance of the company Core Data Sheet (CDS), US PI and EU SmPC.
• ensuring compliance with applicable Health Authority (HA) regulations and guidelines, internal company procedures, company core position and business objectives,
• managing the review and documentation of country labeling deviations for assigned products.

Key Responsibilities/Scope of the Job

• Lead the development, implementation, and maintenance of the CDS, US PI and EU SmPC for Sobi products throughout their lifecycle via the Labeling Working Groups (LWG). Collaborate with internal stakeholders and 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.
• Document and archive the outcome of LWG meetings.
• Present outcomes to the Executive Labeling Committee for approval, where required.
• 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 US PI.
• Collaborate with local/regional RA in their development of 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 Labeling Operations Coordinators (LOCs) 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.

Required: 

• Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific field, e.g. in Pharmacy, Medicine, or Life or Natural Sciences.
• At least 8 years of working experience in the pharmaceutical industry or at a regulatory authority, with at least 5 years of experience in Regulatory Affairs, including CDS and EU/US Labeling experience.
• Experience of working in a global cross functional environment.

Desired: 

• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
• Excellent personal and intercultural skills.
• 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.

Skills/Knowledge/Languages

• Above-average proficiency with basic technology tools (e.g. MS-Office, etc.)
• Experience in Regulatory Information Management systems.
• 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 analyzing & solving problems, with minimal supervision and exceptionally keen skills for attention to detail.
• Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.

The base salary pay range for this role is $155,000-$190,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

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 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 diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.