Global Regulatory Affairs Lead

Company Description

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.

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

Job Description

Key Responsibilities and Accountabilities:
Including, but not limited to the following

• Single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) 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 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 in-licensing matters
• May have direct oversight/management of Regulatory Affairs team members supporting assigned program(s)
• 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
• Experience in haematology is preferred
• Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

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 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 disease