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Senior Regulatory Affairs CMC Associate

3 weeks ago
United States
Full-time
Senior
Compliance Manager
Operations
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 6

Description

  • Support planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications and amendments.
  • Prepare and adapt submission documents for global clinical and commercial filings in line with eCTD specifications and market-specific requirements.
  • Independently plan and prepare routine clinical trial application amendments and commercial submissions, including annual reports, DSURs, and 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.
  • Facilitate communication with vendors and CROs to plan and track source documents for IND, IND amendments, CTA, and EU-CTR submissions.
  • Support implementation of regulatory strategy for projects across all stages of development, from IND through NDA/BLA approval and commercialization.
  • Work with submission authors and reviewers to ensure documents are complete, high quality, and approved on schedule.
  • Prepare and compile presentations for internal and external audiences as needed.
  • Contribute to CMC life cycle management with an emphasis on change management.

Requirements

  • BS 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 8 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 international regulations and procedures in drug/biologics development, including familiarity with ICH and regional requirements.
  • Familiarity with ICH eCTD structure and major market post-approval change requirements.
  • Advanced skills in Microsoft Office Suite, including Word, PowerPoint, and Excel, and Adobe Acrobat Pro.
  • High attention to detail and accuracy.
  • Excellent written communication skills with the ability to build defensible arguments from data, literature, industry standards, and regulations.
  • Strong organizational and planning skills.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to work independently and collaboratively in a fast-paced small company environment and adjust to changing priorities.

Benefits

  • Annual base salary of $140,000 to $160,000 USD.
  • Remote work environment available.
  • Professional workplace or remote office setup.
  • Equal opportunity employer with a diverse and inclusive work environment.
  • Reasonable accommodations available upon request for applicants and employees with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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