Senior Regulatory Affairs Specialist

Iovance seeks a highly motivated Senior Regulatory Affairs Specialist. The successful candidate has substantial experience planning and managing regulatory authority submissions. They will independently with limited supervision manage multiple clinical programs and contribute to the execution of major submissions and responses to regulatory authorities related to IND/NDA submissions and amendments, support preparation of briefing packages for FDA meetings, and support the preparation and submission of routine regulatory documents such as Annual Reports/DSURs, Investigator Packages, and SUSARs. The Senior Associate will represent Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role.

• Responsible for submission planning, oversight of planning of IND related activities like Annual reports, Orphan drug reports, DSUR and other CTA activities for on-going study or study start-ups
• Managing the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepares routine IND and CTA amendments, for example, Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Independently, under limited supervision manages Vendors / CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
• Independently manages tracker for submissions across the multiple products.
• Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Prepares templates or shells for specific submissions based on company standards.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Other duties as assigned.

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.

• 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.

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.