Regulatory Affairs Consultant - Regulatory Generalist

Parexel•Southport, NC

5d•Hybrid

About The Position

Parexel is seeking a highly organized, collaborative Regulatory Affairs Consultant - Generalist to provide end-to-end regulatory support for a strategic pharmaceutical partnership and its development and commercial programs. This role offers the opportunity to contribute across the regulatory lifecycle, from IND maintenance and health authority interactions through NDA submissions and post-approval commitments. Working at the center of cross-functional and alliance teams, you will translate regulatory strategy into well-coordinated, high-quality deliverables. You will combine hands-on Module 1 authoring and submission management with regulatory intelligence, health authority meeting support, lifecycle maintenance, documentation governance, and Global Regulatory Team coordination. The ideal candidate brings strong U.S. regulatory execution experience, sound judgment, and the ability to keep complex activities moving across multiple assets and stakeholders.

Requirements

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.

Nice To Haves

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

Responsibilities

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 to support regulatory strategy materials for program, governance, and alliance discussions.
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.