Senior Regulatory Affairs CMC Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in managing the planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications, including their amendments.

• Prepare and modify submission documents to comply with global clinical and commercial submission requirements, adhering to eCTD specifications and market-specific guidelines.

• May take charge of independently planning and preparing routine clinical trial application amendments and commercial submissions (such as Annual reports, DSUR, and health authority queries).

• Independently oversees submission trackers to coordinate submissions across various products.

• Keeps records of clinical and commercial submissions and communications with the FDA or other regulatory bodies.

• Facilitate interactions with vendors/CROs for the planning and tracking of source documents, ensuring timely delivery of high-quality IND, IND amendments, CTA, and EU-CTR submissions.

• Support the execution of regulatory strategy for assigned projects and programs throughout all development phases (from IND to NDA/BLA approval and commercialization).

• Collaborates with submission authors and reviewers to ensure that source document planning is thorough and that high-quality documents are approved on schedule, focusing on scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory guidelines and processes.

• Design and compile effective presentations for both external and internal audiences as required.

• Generate documents in line with eCTD specifications.

• Undertake miscellaneous tasks as assigned.

⛳️ Requirements

• Bachelor’s degree required; advanced degree (PharmD, PhD, Master’s) preferred.

• Strong scientific or research background, preferably in pharmacy, chemistry, or biology (or relevant experience).

• A minimum of 8 years’ experience in regulatory affairs or a related field within drug/biologic development.

• Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format is advantageous.

• Knowledge of US and international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.

• Understanding of ICH eCTD structure, knowledge of major market post-approval change requirements, and the ability to evaluate the impact on CMC content for clinical and commercial applications.

• Proficient in Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.

• Exceptional attention to detail and accuracy.

• Excellent writing skills with the capacity to construct defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.

• Strong organizational and planning skills are essential.

• High motivation and proactiveness are necessary to engage with both in-person and remote team members.

• Outstanding interpersonal, verbal, and written communication skills.

• Capability to work independently as well as collaboratively within a team.

• Comfortable in a fast-paced small company environment, with the ability to adapt workload according to changing priorities.

🏝️ Benefits

• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.