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.
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