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Regulatory Affairs CMC Associate II

1 hour, 8 minutes ago
United States
Full-time
Senior
Compliance Manager
Legal
Apply Now
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007
View All Jobs 4

Description

  • Support the planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications and amendments.
  • Prepare and adapt submission documents for global filings in accordance with eCTD specifications and market-specific requirements.
  • Independently plan and prepare routine clinical trial application amendments and commercial submissions, including annual reports, DSURs, and responses to health authority queries.
  • Manage submission trackers across multiple products to coordinate filing activities.
  • Maintain logs of clinical and commercial submissions and correspondence with the FDA and other regulatory agencies.
  • Coordinate with vendors and CROs to track source documents and support timely IND, IND amendment, CTA, and EU-CTR submissions.
  • Support implementation of regulatory strategy for projects across the development lifecycle from IND through NDA/BLA approval and commercialization.
  • Work with authors and reviewers to ensure source document planning is complete and submission documents are scientifically accurate, consistent, and on schedule.
  • Prepare and compile presentations for internal and external audiences.
  • Create documents in accordance with eCTD specifications.

Requirements

  • Bachelor’s degree required; advanced degree such as PharmD, PhD, or Master’s preferred.
  • Strong scientific or research background in pharmacy, chemistry, or biology preferred, or equivalent relevant experience.
  • Minimum 5 years of experience in regulatory affairs or a related function in drug or biologic development.
  • Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format is a plus.
  • Understanding of US and ex-US regulatory procedures in drug/biologics development, including ICH and regional requirements.
  • Familiarity with ICH eCTD structure and major market post-approval change requirements.
  • Advanced proficiency with Microsoft Office Suite, including Word, PowerPoint, and Excel, plus Adobe Acrobat Pro.
  • High attention to detail, accuracy, and excellent organizational and planning skills.
  • Excellent written, verbal, and interpersonal communication skills, with the ability to build defensible arguments from data, literature, standards, and regulations.
  • Ability to work independently and collaboratively in a fast-paced small-company environment and adjust priorities as needed.

Benefits

  • Annual base salary range of $120,000 to $140,000 USD.
  • Remote office work environment with a #LI-remote designation.
  • Opportunity to work in a professional workplace or remote office setting.
  • Equal opportunity employer with a diverse and inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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