Senior Associate, Regulatory Affairs

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

📋 Description

• Strategize, monitor, and implement U.S. regulatory submissions to the FDA for both investigational and commercial products.

• Oversee the preparation and execution of INDs, NDAs, BLAs, amendments, and supplements.

• Create regulatory submission documents, including components for INDs.

• Examine regulatory documentation for accuracy, consistency, and completeness.

• Act as the primary execution lead and cross-functional coordinator for designated U.S. submissions.

• Convert regulatory plans into actionable submission timelines and deliverable strategies in collaboration with U.S. Regulatory Strategists.

• Gather and organize FDA submission-ready documents in conjunction with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams.

• Conduct quality-control checks for eCTD technical specifications and FDA requirements.

• Collaborate with Regulatory Publishing to ensure timely, first-cycle-quality FDA submissions.

• Maintain archives for IND, NDA, and BLA, ensuring version control, document integrity, and readiness for inspections.

• Request FDA application numbers via the CDER NextGen Portal and track correspondence from the FDA.

• Utilize Veeva Vault RIM and submission trackers to keep tabs on milestones, deliverables, and risks.

• Stay updated on FDA guidance changes and aid in the continuous enhancement of U.S. submission processes.

• Support regulatory strategies aimed at achieving the earliest possible approvals or clearances.

• Manage the preparation, writing, assembly, review, and timely submission of regulatory dossiers both in the U.S. and internationally.

⛳️ Requirements

• A BA/BS degree, preferably in a scientific or health-related field, accompanied by 2+ years of experience OR 5+ years of experience in Regulatory Affairs, including hands-on support for U.S. IND preparation (mandatory).

• At least 3 years of direct experience in preparing and executing FDA submissions (IND, NDA, BLA) along with lifecycle management activities.

• Prior experience in Regulatory Affairs; practical knowledge in U.S. IND preparation and familiarity with NDA submissions and associated amendments or supplements.

• Experience with CTD/eCTD formats.

• Proficient in publishing documents using Adobe Acrobat Professional.

• Working knowledge of FDA and ICH regulatory guidance and regulations is preferred.

• Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Capacity to manage submission timelines, trackers, and Master Document Lists effectively.

• Excellent organizational and documentation skills.

• Ability to handle multiple U.S. submissions and priorities concurrently.

• Capable of working both independently and collaboratively under stringent FDA-driven timelines.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards available.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance benefits.

• Paid Time Off (PTO).

• Wellness benefits offered.