.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 workEmphasis on work/life balanceCollaborative and team-oriented environmentOpportunities for professional growthDiversity and InclusionMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob DescriptionKey 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' accessAttends 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 consultantsParticipates in strategic and regulatory evaluations of in-licensing mattersMay 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 signatoriesReview regulatory SOPs as neededParticipate 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
