RemoteLeaf Logo
Log in Sign up

Regulatory Affairs CMC Associate II

1 month, 2 weeks 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 8

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

Similar Roles

StraitsX

Compliance Manager (Customer Due Diligence)

StraitsX 11-50 Diversified Financial Services

Compliance Manager (Customer Due Diligence) at a regulated financial services company, leading the CDD function for high-risk onboarding, ongoing monitoring, and due diligence governance across corporate customers, individuals, and card programs.

Singapore Senior Compliance Manager
7 hours, 33 minutes ago
Fast Affordable Solutions

Regulatory Specialist – Study Start-Up

Fast Affordable Solutions Professional Services

UniTriTeam is hiring a Regulatory Specialist – Study Start-Up to support a clinical research client with study activation, regulatory submissions, and an eRegulatory system migration to Florence.

Egypt Contract Junior Compliance Manager
GCP HIPAA
8 hours, 3 minutes ago
Precision Medicine Group

Regulatory and Site Start Up Specialist

Precision Medicine Group 251-1K Pharmaceuticals

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to manage country-level clinical trial submissions, site activation readiness, and regulatory coordination for oncology and rare disease studies.

China Full-time Junior Compliance Manager Contract Manager
1 day, 7 hours ago
Affirm

Compliance Manager

Affirm 1K-5K Diversified Financial Services

Affirm is hiring a Regulatory Compliance Manager, Australia to lead its local compliance program for consumer credit and related financial services, ensuring regulatory obligations are met while supporting responsible growth and strong consumer outcomes.

Australia Full-time Lead Compliance Manager
$89k-$135k
1 day, 7 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers