Regulatory Affairs Consultant – Regulatory Generalist

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

📋 Description

• Lead or assist in the creation, assembly, quality review, and management of submissions for IND Module 1 content and other U.S. administrative submission elements.

• Maintain comprehensive tables of contents and submission trackers that detail content ownership, status, dependencies, approvals, and readiness for publishing.

• Coordinate regulatory publishing, document management, asset management, and subject matter experts to produce submission packages.

• Draft and coordinate the preparation of FDA forms, cover letters, submission metadata, and other administrative documents.

• Oversee review and approval workflows, resolve any content or formatting discrepancies, and manage publishing and submission transitions.

• Provide support for INDs, NDAs, supplements, amendments, and related communications with health authorities.

• Author and organize requests for health authority meetings, briefing documents, meeting packages, and other administrative components.

• Coordinate responses to FDA information requests, including reviews, timelines, and final submissions.

• Archive correspondence and meeting records related to health authorities, ensuring indexing, version control, and traceability.

• Prepare and coordinate lifecycle submissions for IND and NDA, which include protocol amendments, investigator updates, CMC amendments, Investigator’s Brochure updates, annual reports, supplements, and post-approval submissions.

• Author or coordinate regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator’s Brochures, and periodic or safety-related reports.

• Conduct regulatory intelligence searches and compile findings into presentations focused on decision-making.

• Prepare materials for Global Regulatory Team, governance, and alliance meetings.

• Organize agendas, functional updates, decisions, actions, and alignment on program milestones.

• Represent Regulatory Affairs in meetings with the Global Regulatory Team, clinical trials, partners, and alliances.

• Collaborate with Clinical, CMC, Nonclinical, Safety, Quality, Commercial, Regulatory Operations, Publishing, and Asset Management teams.

• Maintain U.S. regulatory archive logs and file submissions, correspondence, and partner documentation.

• Upload and manage correspondence and regulatory records from global partners.

• Ensure proper indexing, metadata, version control, traceability, and readiness for inspections using RIM, EDMS, and other relevant tools.

• Keep track of Form FDA 1572 waivers and clinical documentation, author waiver requests, and assist with related submissions.

• Conduct regulatory reviews of study start-up documentation to ensure IND-level compliance.

⛳️ Requirements

• A minimum of 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry.

• Direct experience with authoring IND Module 1, submission assembly, TOC tracking, and collaboration with regulatory publishing or submission operations.

• Proven experience in IND lifecycle maintenance, including protocol amendments, investigator updates, CMC amendments, and Investigator’s Brochure updates.

• Experience in supporting NDA submissions and lifecycle maintenance, including annual reports and post-approval activities.

• Background in authoring or coordinating requests for health authority meetings, briefing documents, responses to FDA information requests, and health authority communications.

• Familiarity with contributing to PADERs, DSURs, PSURs/PBRERs, Investigator’s Brochures, or related regulatory sections.

• Experience in conducting regulatory intelligence research and presenting findings to guide regulatory strategy and planning.

• Demonstrated ability to prepare materials for Global Regulatory Team, governance, or alliance meetings and coordinate cross-functional contributions.

• Experience working collaboratively across Clinical, CMC, Nonclinical, Safety, Quality, Regulatory Operations, Publishing, and related functions.

• Strong skills in regulatory writing, document coordination, and submission management.

• Ability to distill guidelines and regulatory precedents into clear, decision-oriented presentations.

• Excellent organizational and project management skills, adept at handling multiple assets, deadlines, contributors, and review cycles.

• High attention to detail and a commitment to quality in submissions, document control, and readiness for inspections.

• A client-focused, consultative approach with robust interpersonal and cross-cultural communication skills.

• Capacity to work effectively within matrixed, cross-company, and alliance environments.

• Strong critical thinking, problem-solving, results-oriented mindset, and sound judgment in fast-paced settings.

• Exceptional written and verbal communication skills in English; proficiency in the local language is preferred where applicable.

• Preferred knowledge of RIM, EDMS, and electronic submission processes.

• A Bachelor’s degree in a scientific, technical, or related field is required.

• Preference for candidates located in the Eastern or Central time zones of the United States or Canada.

🏝️ Benefits

• Paid time off.

• 401(k) matching.

• Life insurance.

• Health insurance.

• Additional benefits in line with applicable plans.

• Potential eligibility for further incentives, bonuses, or other compensation programs.

• Flexible work environment.

• Opportunities for growth.