Regulatory Affairs CMC Associate II

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

📋 Description

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

• Prepare and modify submission documents for global clinical and commercial submissions in accordance with eCTD specifications and market-specific requirements.

• May take charge of independently planning and preparing routine amendments related to clinical trial applications and commercial submissions (e.g., annual reports, DSUR, health authority queries).

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

• Maintains records of clinical and commercial submissions and correspondence with the FDA or other regulatory bodies.

• Enhance communication with vendors/CROs to plan and track source documents, ensuring timely delivery of high-quality IND, IND amendments, CTA, and EU-CTR submissions.

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

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

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

• Generate documents in alignment with eCTD specifications.

⛳️ Requirements

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

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

• A minimum of 5 years of experience in regulatory affairs or a related role within drug/biologic development.

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

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

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

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

• Exceptional attention to detail and accuracy.

• Strong written communication skills with the ability to construct defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.

• Excellent organizational and planning abilities are essential.

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

• Outstanding interpersonal, verbal, and written communication skills.

• Capability to work both independently and collaboratively as part of a team.

🏝️ Benefits

• Health insurance

• Paid time off

• Professional development

• Remote work options

• Flexible work hours