Global Regulatory Lead

• Single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s)
• Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)
• Provides global regulatory leadership of assigned program(s)
• Develops global regulatory strategies including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients access
• Attends major/critical regulatory Agency meetings (US FDA EMA/CHMP PMDA NMPA/CDE) for assigned program(s)
• May act as the European or US Regulatory Strategy lead (jointly with GRL role) depending on the complexity of the program and stage of development
• May present to Senior Leadership regarding assigned program(s)
• Cooperates with other departments and affiliates within Sobi regulatory authorities partners and regulatory consultants
• Participates in strategic and regulatory evaluations of inlicensing matters
• May have direct oversight of Regulatory Affairs team members supporting assigned program(s). Develops and coaches direct reports
• Authority to approve services and costs within budget and delegation from Sobi authorized signatories
• Review regulatory SOPs as needed
• Participate in operational excellence work (improvement projects) as needed

Main contacts:

• Internal core interactions: All functions within Sobi but in particular Commercial Pharmacovigilance & Patient Safety Supply Chain Quality Manufacturing & Supply Clinical Development Global Medical & Scientific Affairs Project & Portfolio Management as well as Management Teams Governance Teams and affiliates.
• External core interactions with: Regulatory Authorities CROs Consultants Partners.
• May act as point of contact with US FDA or EMA

Qualifications :

• Degree in Life Sciences
• Expert on all Regulatory Affairs processes applications and regulatory environment to achieve and maintain marketing authorizations
• Good knowledge of drug development and the rare diseases regulatory environment
• Very good knowledge in written and oral English knowledge of other languages is an upside but not required

Personal attributes:

• Strong teamplayer with collaborative respectful and flexible attitude and high engagement
• Highly selfmotivated and able to drive activities solutionoriented personality
• Excellent communication and negotiation skills

The suitable candidate should demonstrate the Sobi Values; Care for our patients for our colleagues and for our company Ambition Urgency Ownership and Partnership.

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis 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 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 firsthand 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 groundbreaking 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 cant 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

COVID19 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 COVID19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any statespecific exemptions as required by applicable law.