Senior Regulatory Affairs CMC Associate

Responsibilities

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments.
• Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements.
• May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries).
• Independently manages submission trackers for coordination of submissions across multiple products.
• Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies.
• Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Create documents in accordance with eCTD specifications.
• Perform miscellaneous duties as assigned.

Requirements

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.
• Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience).
• Minimum 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.
• Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
• Familiarity with ICH eCTD structure, knowledge of major market post approval change requirements, and ability to assess impact to CMC content clinical and commercial applications.
• Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.
• Excellent organizational and planning skills is a requirement.
• High level of motivation and proactiveness required to engage in both in-person and remote team members.
• Excellent interpersonal, verbal and written communication skills.
• Ability to work both independently and collaboratively as part of a team.
• Comfortable in a fast-paced small company environment with ability to adjust workload based upon changing priorities.