Regulatory Affairs Consultant - Regulatory Generalist

Overview

Regulatory Affairs Consultant - Generalist providing end-to-end regulatory support for a strategic pharmaceutical partnership and its development and commercial programs, spanning IND maintenance, health authority interactions, NDA submissions and post-approval commitments.

What you'll do

• Lead or support authoring, assembly, quality review, and submission management for IND Module 1 content and other U.S. administrative submission components.
• Maintain detailed tables of contents and submission trackers to provide visibility to content ownership, status, dependencies, approvals, and publishing readiness.
• Coordinate with regulatory publishing, document management, asset management, and subject matter experts to deliver complete, accurate, and timely submission packages.
• Draft and coordinate FDA forms, cover letters, submission metadata, and supporting administrative documentation.
• Manage review and approval workflows, resolve content or formatting gaps, and oversee handoffs through established publishing and submission processes.
• Support major regulatory submissions, including INDs, NDAs, supplements, amendments, and related health authority correspondence.
• Author and coordinate health authority meeting requests, briefing documents, meeting packages, and associated administrative components.
• Establish timelines, coordinate subject matter expert input, track reviews, and support finalization and submission.
• Coordinate FDA information request responses by engaging appropriate subject matter experts, consolidating content, and managing review cycles and timelines.
• Archive health authority correspondence and meeting records with accurate indexing, version control, and traceability.
• Ensure actions, commitments, and follow-up activities are documented and routed to the appropriate stakeholders.
• Prepare and coordinate IND and NDA lifecycle submissions, including protocol amendments, investigator updates, CMC amendments, Investigator's Brochure updates, annual reports, supplements, and other regulatory maintenance activities.
• Author or coordinate applicable regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator's Brochures, and other periodic or safety-related reports with cross-functional contributors.
• Prepare, review, and coordinate NDA Annual Reports and other required post-approval submissions.
• Maintain visibility to commitments, reporting obligations, submission deadlines, and lifecycle deliverables.
• Conduct targeted regulatory intelligence searches to identify relevant health authority guidelines, policies, and regulatory precedents.
• Synthesize findings into clear, decision-oriented slide decks to guide upcoming regulatory activities and strategic discussions.
• Highlight implications, comparable precedents, potential considerations, and information gaps for regulatory leadership and program teams as requested.
• Prepare high-quality slide decks for monthly or quarterly Global Regulatory Team meetings, governance discussions, and alliance meetings, based on each program's cadence.
• Coordinate agenda content, consolidate functional updates, track decisions and actions, and help keep deliverables aligned with program milestones.
• Participate in Global Regulatory Team, clinical trial team, and partner or alliance meetings as a Regulatory Affairs representative.
• Collaborate with Clinical, CMC, Nonclinical, Safety, Quality, Commercial, Regulatory Operations, Publishing, and Asset Management colleagues.
• Maintain U.S. regulatory archive logs, record new submissions, and file health authority correspondence and partner documentation promptly and accurately.
• Upload and manage correspondence and regulatory records received from global partners.
• Ensure proper indexing, metadata, version control, and traceability using RIM, EDMS, and other applicable tools.
• Maintain complete, inspection-ready records aligned with internal procedures and regulatory expectations.
• Maintain Form FDA 1572 waiver and clinical documentation trackers; author waiver requests and support related submissions, as needed.
• Conduct regulatory reviews of study start-up documentation, as assigned, to support IND-level compliance.

What you'll need

• 5+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry, supporting pre-approval development and post-approval lifecycle activities.
• Hands-on experience with IND Module 1 authoring, submission assembly, TOC tracking, and coordination with regulatory publishing or submission operations.
• Direct experience with IND lifecycle maintenance, including protocol amendments, investigator updates, CMC amendments, and Investigator's Brochure updates.
• Experience supporting NDA submissions and lifecycle maintenance, including annual reports and post-approval activities.
• Experience authoring or coordinating health authority meeting requests, briefing documents, FDA information request responses, and health authority correspondence.
• Experience contributing to PADERs, DSURs, PSURs/PBRERs, Investigator's Brochures, or associated regulatory sections.
• Experience conducting regulatory intelligence research and presenting guidelines or precedents to inform regulatory planning or strategy.
• Proven ability to prepare Global Regulatory Team, governance, or alliance meeting materials and coordinate cross-functional inputs.
• Experience working across Clinical, CMC, Nonclinical, Safety, Quality, Regulatory Operations, Publishing, and related functions.
• Strong regulatory writing, document coordination, and submission management capabilities.
• Ability to translate guidelines and regulatory precedents into concise, decision-focused presentations.
• Excellent organization and project management skills across multiple assets, deadlines, contributors, and review cycles.
• High attention to detail and commitment to submission quality, document control, and inspection readiness.
• Client-focused, consultative approach with strong interpersonal and cross-cultural communication skills.
• Ability to work effectively across matrixed, cross-company, and alliance environments.
• Critical thinking, problem-solving, results orientation, and sound judgment in a fast-moving environment.
• Excellent written and verbal English communication skills; proficiency in the local language, where applicable.
• Bachelor's degree in a scientific, technical, or related discipline required.

Nice to have

• Working knowledge of RIM, EDMS, and electronic submission processes.
• Advanced degree.
• Candidates located in the Eastern or Central time zones of the United States or Canada.

Details

• Location: United States - Remote.