Iovance Biotherapeutics, Inc. logo
Iovance Biotherapeutics, Inc.

Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.

Regulatory Affairs CMC Associate II

ComplianceComplianceFull TimeRemoteMid LevelTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

17 days ago

Salary

$120K - $140K / year

Seniority

Mid Level

Bachelor Degree5 yrs expEnglish

Job Description

Regulatory Affairs CMC Associate II

Iovance Biotherapeutics, Inc.

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments. • Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements. • May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries). • Independently manages submission trackers for coordination of submissions across multiple products. • Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies. • Facilitate communication with 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. • Prepare and compile effective presentations for external and internal audiences as needed. • Create documents in accordance with eCTD specifications.

Job Requirements

  • 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 5 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.
  • Familiarity with ICH eCTD structure, knowledge of major market post approval change requirements, and ability to assess impact to CMC content clinical and commercial applications.
  • Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
  • High attention to detail and accuracy.
  • Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.
  • Excellent organizational and planning skills is a requirement.
  • 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 both independently and collaboratively as part of a team.

Benefits

  • Health insurance
  • Paid time off
  • Professional development
  • Remote work options
  • Flexible work hours

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