Key Responsibilities and Required Skills for Regulatory Affairs Project Manager

🎯 Role Definition

The Regulatory Affairs Project Manager is a strategic, cross-functional leader responsible for planning, coordinating and delivering regulatory activities across product development and lifecycle stages. This role leads global submission programs (e.g., IND, NDA, BLA, MAA, 510(k), PMA), drives regulatory strategy and timelines, manages regulatory risk and compliance, and serves as the primary liaison with health authorities and internal stakeholders to ensure timely approvals and product market access.

Key keywords: Regulatory Affairs Project Manager, regulatory strategy, regulatory submissions, FDA, EMA, global regulatory, eCTD, GxP compliance, product lifecycle, labeling, post-market surveillance, project management.

📈 Career Progression

Typical Career Path

Entry Point From:

Regulatory Affairs Specialist / Associate (pharmaceuticals or devices)
Clinical Project Manager or Clinical Regulatory Specialist
Quality Assurance Specialist with regulatory exposure

Advancement To:

Senior Regulatory Affairs Project Manager
Regulatory Program Lead / Head of Regulatory Affairs
Global Regulatory Strategy Lead or Director of Regulatory Affairs

Lateral Moves:

Quality Assurance Manager (GxP/Compliance)
Clinical Operations or Clinical Development Manager
Product Development or Commercial Launch Program Manager

Core Responsibilities

Primary Functions

Develop, implement and manage regulatory submission plans and timelines (e.g., IND, NDA, BLA, MAA, 510(k), PMA, de novo), coordinating cross-functional deliverables to ensure on-time submission and approval across jurisdictions (US, EU, APAC, LATAM).
Lead the preparation, review and assembly of complex regulatory dossiers (CTD/eCTD, eCTD modules, device technical files) including content management, version control, and final delivery to health authorities.
Define and execute global regulatory strategies that align with clinical development, CMC (chemistry, manufacturing and controls), quality, and commercial goals; provide actionable regulatory advice to project teams and senior leadership.
Manage interactions with regulatory authorities (FDA, EMA, MHRA, PMDA, ANVISA, etc.), prepare briefing documents, pre-submission packages, and coordinate responses to information requests, deficiency letters and Day 74/120 meetings.
Coordinate submission readiness activities for product launches and life-cycle management, including labeling negotiations, indications, labeling updates, and risk mitigation strategies across regions.
Drive regulatory risk assessments and scenario planning for program milestones; propose mitigation plans and regulatory alternatives to maintain program timelines and commercial objectives.
Oversee regulatory intelligence activities to monitor changes in global regulations, guidance, and competitor filing activities; translate intelligence into operational changes and strategic recommendations.
Serve as program manager for cross-functional regulatory projects, managing budgets, timelines, resource allocation, and integrated project plans using PM tools (MS Project, Smartsheet, Jira, or similar).
Facilitate cross-functional regulatory governance meetings, prepare regulatory status reports, escalations and decision documents for senior management and steering committees.
Ensure regulatory compliance with GxP requirements and corporate policies during submissions and product lifecycle activities; collaborate with QA for audits, inspections and corrective action plans.
Lead due-diligence and regulatory assessments for licensing, mergers & acquisitions, or partnership agreements; prepare regulatory sections for RFPs, LOIs, and technical documentation reviews.
Manage external consultants, regulatory affairs vendors and CROs; define scopes of work, evaluate deliverables and ensure alignment with program timelines and quality expectations.
Coordinate nonclinical and clinical regulatory requirements, including IND maintenance, safety reporting (e.g., SUSARs, PSURs), and regulatory aspects of clinical trial submissions and amendments.
Oversee dossier translations, local regulatory submissions and regional registration strategies; ensure localization of labeling and regulatory documents meets local authority requirements.
Develop and maintain regulatory tools, templates, SOPs and submission checklists to standardize processes and improve submission quality and efficiency.
Lead labeling strategy, artwork coordination and regulatory packaging reviews in collaboration with Marketing, Medical Affairs and Legal to ensure compliant promotional materials and product information.
Provide regulatory training and mentorship to project teams and junior regulatory staff; build regulatory capability across the organization and contribute to continuous improvement initiatives.
Manage post-market activities including change control, variations, supplements, reformulations, and post-approval commitments (e.g., PMCs, REMS), ensuring regulatory obligations are met on time.
Prepare and manage responses to regulatory inspections and audits; liaise with inspection teams, coordinate evidence generation, and lead root cause analysis and corrective actions.
Drive effective communication between cross-functional stakeholders (R&D, CMC, Clinical, QA, Manufacturing, Commercial) to ensure transparency of regulatory timelines, risks and milestone interdependencies.
Support pricing, market access and reimbursement teams by providing regulatory input related to indication, labeling constraints and approved claims that impact HTA submissions.
Ensure ethical and compliant promotional claims and advertising materials by reviewing regulatory impact and providing clearance for launch materials in coordination with Legal and Medical.
Maintain meticulous recordkeeping for regulatory activities, correspondence with authorities, and dossier history to ensure audit readiness and regulatory traceability.

Secondary Functions

Provide regulatory input into early product development and feasibility assessments to inform go/no-go decisions and development stage gating.
Support regulatory budgeting, vendor selection and contract management for regulatory-related activities and external service providers.
Contribute to regulatory aspects of manufacturing tech transfer, site qualification and CMC remediation plans.
Participate in cross-functional process improvement projects to reduce submission cycle times and increase first-time approval rates.
Mentor and coach junior regulatory staff, contributing to talent development and succession planning within the regulatory organization.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of global regulatory submission formats and requirements: CTD/eCTD, non-CTD, eCopy, and portal-based submissions.
Regulatory strategy development for drugs, biologics, combination products and medical devices including lifecycle management and post-market changes.
Hands-on experience managing FDA, EMA, MHRA and other health authority interactions, meetings and written communications.
Strong understanding of GxP regulations (GMP, GLP, GCP) and their impact on regulatory submissions and compliance.
Proficiency with submission management tools and content management systems (e.g., eCTD publishing software, Veeva Vault, Lorenz, Extedo).
Experience with project management tools and methodologies: MS Project, Smartsheet, Jira, Agile/Scrum fundamentals for regulatory program coordination.
Ability to author and scientifically review regulatory documents: briefing packages, regulatory strategy papers, responses to RAI, safety narratives, IMPDs and clinical study reports.
Knowledge of pharmacovigilance and safety reporting requirements, including PSURs/PBRERs, IND safety reporting and local adverse event reporting obligations.
Familiarity with labeling development, regulatory packaging review, and local language adaptation requirements.
Experience managing external vendors, CROs, regulatory consultants, and third-party publishers with strong contract and deliverable oversight.
Data literacy: ability to interpret clinical and CMC data to inform regulatory arguments and filing strategies.
Regulatory intelligence gathering and application to strategy — keeping current with guidance changes and new regulatory pathways (breakthrough, PRIME, accelerated approvals).

Soft Skills

Excellent stakeholder management and interpersonal communication skills; able to influence cross-functional teams and senior executives.
Strong analytical and strategic thinking with the ability to translate scientific data into regulatory rationale and actionable plans.
Proven leadership and team management skills, including mentorship and development of junior regulatory professionals.
Exceptional written and verbal communication skills for clear regulatory submissions and authoritative responses to agencies.
High attention to detail, organization, and ability to manage multiple complex projects and priorities simultaneously.
Problem-solving mindset with resilience under regulatory pressure and changing timelines.
Negotiation skills for labeling discussions and authority interactions.
Cultural sensitivity and adaptability for managing international regulatory teams and multi-region submissions.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in life sciences, pharmacy, regulatory science, biomedical engineering, or related discipline.

Preferred Education:

Advanced degree (MS, MPH, PharmD, PhD) in regulatory science, life sciences, pharmaceutical sciences, or related field.

Relevant Fields of Study:

Regulatory Affairs / Regulatory Science
Pharmacy / Pharmaceutical Sciences
Life Sciences / Biology / Biochemistry
Biomedical Engineering / Medical Devices
Public Health / Clinical Research

Experience Requirements

Typical Experience Range: 5–10+ years in regulatory affairs, with demonstrated experience in project leadership and global submissions.

Preferred:

7+ years managing regulatory programs for pharmaceuticals, biologics, combination products or medical devices, including at least one full life-cycle submission to major regulatory authorities (FDA, EMA).
Direct experience with eCTD publishing, regulatory inspection readiness, and cross-functional program leadership.