Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Senior Associate, Regulatory Affairs CMC
Location
United States
Posted
3 days ago
Salary
$140K - $160K / year
Seniority
Senior
Job Description
Senior Associate, Regulatory Affairs CMC
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. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.
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).
- 8 years’ experience in regulatory affairs or a related function in drug/biologic development with a bachelor’s degree, 6+ years’ experience with a master’s degree, or 3+ years with a PhD
- 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.
- Comfortable in a fast-paced small company environment with ability to adjust workload based upon changing priorities.
Benefits
- Competitive salary
- Remote work options
- Paid time off
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