GLOBAL REGULATORY AFFAIRS LEAD

Company DescriptionStatistics 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 TeamCompetitive 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 followingSingle 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 ContactsInternal 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 EMAQualificationsDegree in Life SciencesExpert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizationsGood knowledge of drug development and the rare diseases regulatory environmentExperience in haematology is preferredVery good knowledge in written and oral English, knowledge of other languages is an upside but not requiredAdditional InformationAll 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 CultureAt 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 EmployerSobi 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 florencia.mendez@sobi.com.