Iovance Biotherapeutics - Senior Regulatory Affairs Specialist

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred. Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience). • Minimum 8 years’ experience in regulatory affairs or a related function in drug/biologic development. • Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus. • Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements. • Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro. • High attention to detail and accuracy. • High level of motivation and proactiveness required to engage in both in-person and remote team members. • Excellent interpersonal, verbal and written communication skills. • Ability to work independently with minimal supervision or direction • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities • The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. • Physical Demands and Activities Required • Must be able to remain in a stationary position standing or sitting for prolonged periods of time. • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. • Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. • Must be able to communicate with others to exchange information. • Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. • Mental • Work Environment • Work Environment • This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. • The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills. • Pay Transparency • $140,000—$160,000 USD • The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. • Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected]. • By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.