Manager, Regulatory Affairs

Iovance Biotherapeutics

1d•$140,000 - $160,000•Remote

About The Position

The Manager, Regulatory Affairs, represents 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.

Requirements

BA/BS degree in related field required
8+ years’ experience in regulatory affairs or a related function in drug/biologic development and a Bachelor’s degree, 6+ years with a Master’s degree, or 4+ years with a PhD.
Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format
Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
High attention to detail and accuracy.
Excellent interpersonal, verbal and written communication skills.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Nice To Haves

Advanced degree preferred (or relevant experience).

Responsibilities

Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
Prepares routine IND and CTA amendments.
Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule.
Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers 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.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.