Key Responsibilities and Required Skills for Global Regulatory Team Lead

🎯 Role Definition

The Global Regulatory Team Lead (GRTL) is a strategic leadership position central to our product development and commercial success. This individual is the primary regulatory point of contact for assigned projects, responsible for crafting and executing robust global regulatory strategies. The GRTL provides direction, mentorship, and oversight to a team of regulatory professionals, ensuring all regulatory submissions are of the highest quality and are delivered on time. This role requires a deep understanding of the global regulatory landscape, strong leadership acumen, and the ability to navigate complex cross-functional environments to bring innovative therapies to patients worldwide.

📈 Career Progression

Typical Career Path

Entry Point From:

Principal Regulatory Affairs Specialist
Senior Manager, Regulatory Affairs
Regional Regulatory Lead (e.g., EU or US Lead)

Advancement To:

Director, Global Regulatory Affairs
Global Regulatory Therapeutic Area Head
Vice President, Regulatory Affairs

Lateral Moves:

Director, Regulatory Policy and Intelligence
Director, Regulatory Operations
Senior Director, Quality Assurance

Core Responsibilities

Primary Functions

Develop, champion, and execute forward-thinking global regulatory strategies for products throughout their lifecycle, from early development through post-marketing, ensuring alignment with overall business objectives.
Provide inspirational leadership, mentorship, and direct line management to a team of regulatory affairs professionals, fostering a culture of high performance, accountability, and continuous professional development.
Serve as the primary liaison and build effective working relationships with key global health authorities, including the FDA, EMA, PMDA, and others, leading formal meetings and negotiations.
Direct and oversee the strategic planning, preparation, and submission of high-quality regulatory dossiers, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs).
Lead the regulatory sub-team within the global project team, providing strategic regulatory guidance and ensuring that the project team is aware of regulatory requirements, risks, and opportunities.
Critically review and approve key submission documents, such as protocols, investigator brochures, clinical study reports, and labeling, to ensure they meet regulatory standards and support the strategic objectives.
Proactively identify and assess potential regulatory risks, developing comprehensive mitigation strategies to minimize delays and ensure successful product development and registration.
Maintain expert knowledge of current and emerging regulatory requirements, guidelines, and industry trends, and effectively communicate their impact to internal stakeholders.
Manage the preparation and coordination of responses to inquiries and information requests from global health authorities, ensuring they are timely, complete, and strategically sound.
Oversee all post-approval and product lifecycle management activities, including the submission of variations, supplements, and annual reports to maintain compliance and support product changes.
Represent the regulatory affairs function in cross-functional governance bodies, providing strategic input and ensuring regulatory considerations are integrated into corporate decision-making.
Collaborate closely with key internal partners, including Clinical Development, Non-clinical, CMC, Pharmacovigilance, and Commercial, to ensure a cohesive and integrated approach to product development.
Manage regulatory project timelines, budgets, and resource allocation to ensure departmental and project goals are met efficiently.
Drive the development and implementation of global labeling strategies, including the creation and maintenance of the Company Core Data Sheet (CCDS) and negotiation of regional labels.
Act as a subject matter expert during internal audits and external regulatory inspections, leading preparation activities and front-room/back-room support.

Secondary Functions

Contribute to the development and enhancement of departmental standard operating procedures (SOPs), work instructions, and best practices to improve regulatory operational efficiency and compliance.
Participate in due diligence activities for potential in-licensing, out-licensing, or acquisition opportunities, providing expert regulatory assessment of risks and opportunities.
Support regulatory intelligence activities by monitoring the competitive landscape and providing insights on competitors' regulatory strategies, timelines, and health authority interactions.
Mentor junior regulatory staff outside of direct reporting lines to aid in the development of regulatory talent across the organization.
Represent the company at external conferences and industry forums to stay abreast of best practices and build a professional network.

Required Skills & Competencies

Hard Skills (Technical)

Expert Regulatory Knowledge: Deep, comprehensive understanding of global regulatory frameworks, including ICH guidelines and specific requirements of major health authorities (FDA, EMA, PMDA) for drug/biologic development, registration, and lifecycle management.
Strategic Submission Planning: Demonstrated ability to plan, prepare, and execute complex regulatory submissions (e.g., IND/CTA, NDA/BLA/MAA) from a strategic, content, and operational perspective.
Health Authority Interaction: Proven experience leading and preparing teams for major health authority meetings and successfully negotiating on critical product issues.
Scientific Acumen: Strong ability to interpret and critically evaluate clinical and non-clinical data to ensure it adequately supports regulatory filings.
Project Management: Proficiency in managing multiple complex projects with competing priorities, including timeline management, resource planning, and budgeting.
eCTD Proficiency: Solid working knowledge of the Electronic Common Technical Document (eCTD) structure, submission processes, and associated publishing software.

Soft Skills

Strategic and Critical Thinking: Exceptional ability to analyze complex situations, anticipate future trends, and develop innovative regulatory pathways to achieve business goals.
Leadership and Influence: Proven leadership skills with the ability to inspire, motivate, and develop a team, while also influencing cross-functional partners and senior management without direct authority.
Communication and Negotiation: Superior written and verbal communication skills, with the polish and presence to represent the company and negotiate effectively with internal and external stakeholders, including regulators.
Problem-Solving and Resilience: A proactive and solutions-oriented mindset, with the ability to navigate ambiguity, manage setbacks, and make sound decisions under pressure.
Collaboration and Teamwork: A natural collaborator who can build strong, trusting relationships across departments, functions, and cultures to drive collective success.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in a scientific or health-related discipline.

Preferred Education:

Advanced degree (MS, PhD, PharmD, or MD).
Regulatory Affairs Certification (RAC) is highly desirable.

Relevant Fields of Study:

Pharmacy
Chemistry
Biology or a related life science

Experience Requirements

Typical Experience Range:

10+ years of progressive experience within the pharmaceutical or biotechnology industry, with at least 8 of those years in a direct regulatory affairs role.

Preferred:

Significant experience in a global regulatory leadership capacity, with a track record of successful major submissions in the US and EU.
Direct line management experience, including hiring, performance management, and career development of regulatory professionals.
Experience across multiple therapeutic areas and phases of drug development is a distinct advantage.