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Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

The Director, Global Clinical Regulatory and Labeling Strategy is a key role in GRA organization accountable for the development and implementation of clinical strategy of multiple products in various stages of drug development, and updates to or creation of a core label strategy for the associated products.

Responsibilities include but are not limited to:

Management of Regulatory and Cross-Functional Teams

Leads cross-functional teams with excellent presentation and communication skills to foster collaboration and driving alignment of the product development strategy.

Collaborates with clinical senior management in developing target product profile (TPP) for Novavax programs, and providing high level strategic guidance and leadership on global clinical regulatory and labeling strategies, ensuring that the strategies align with Novavax processes and TPP.

Leads key stakeholder meeting with leadership to drive key program decision-making, and provides leadership and guidance to drive alignment on regulatory and core labeling strategy at the leadership level.

Mentor other regulatory and labeling team members and/or reviews the output of global strategy implementation plans.

Regulatory Intelligence and Precedent Trends in Product Development

Assess and interpret laws, regulations, and guidance documents relevant to the product development and assures that clinical and labeling content and processes conform to regulatory requirements.

Conducts precedent searches, analyzes relevant competitor development programs, product-specific health authority requests, labeling guidance and trends; and develops regulatory strategies to ensure consistency with the overall product strategy, product claims and information in the TPP.

Core Regulatory Documents Authoring, Submission, and Labeling Communications

Independently authors core regulatory and labeling documents (i.e, CCDS), obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.

In a highly efficient manner, develops and executes regulatory strategies to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into core regulatory applications enabling the most up-to-date information and in compliance with Novavax processes.

Where applicable, manages strategies for outgoing communications to partners regarding significant core labeling changes and CCDS changes for assigned products.

Escalation Process and Stakeholder Management

Appropriately escalates issues to Global Regulatory management and proposes risk mitigation strategies for assigned programs.

Establish and cultivate collaborative relationships among functions represented at the Regulatory and Labeling cross functional team meetings, including clinical, non-clinical, CMC and safety, medical affairs, and commercial, to ensure streamlined and effective communication for program strategy and content.

Working within Global Regulatory Affairs Team

Represents program and labeling interests at Global Regulatory management team meetings

Effective communication with cross-functional Clinical/ Non-Clinical and CMC Regulatory Affairs and Regulatory and Labeling Operations to align on product development strategy and ensure core objectives and timelines are met.

Supports Health Authority Inspections by providing regulatory information requests related to assigned programs and overall labeling processes.

Actively contributes to the continuous improvement of core regulatory and labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Education & Experience Requirements:

Bachelor's degree required; advanced scientific degree (MSc, PhD, or PharmD) preferred.

10+ years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 6+ years regulatory/ early phase development. Early phase/ non-clinical development experience required.

In-depth expertise of product development requirements, regulations, and guidelines and proactive evaluation of evolving regulatory landscape, and well as other relevant regional regulatory nuances and requirements.

Understanding of scientific principles and regulatory/quality systems relevant to drug development.

Demonstrated ability to independently create, revise and/or update product labeling (i.e. CCDS) for company compliance.

Ability to review documents for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.

Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.

Strong familiarity with ClinicalTrials.gov, EU Clinical Trials Register, and other pertinent source for trial design.

Ability to quickly understand company organization, functional impact and regional representation to proactively build and cultivate the relationships needed to be successful across functions, departments and regions.

Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.

Key Skills and Competencies:

Team-oriented, have excellent interpersonal, communication, and follow-up skills with strong attention to detail and acts proactively and effectively as member of multi-disciplinary teams.

Able and willing to work in a fast-paced environment while managing multiple priorities

Flexible, detail-oriented, and possess excellent analytical and problem-solving skills

Shows strong initiative and drive; must be an organized self-starter

Knowledgeable in ICH CTD/eCTD structure and requirements

Excellent organizational, presentation and writing skills

Knowledge of MS Office with advanced MS Word and MS PowerPoint skills

Knowledge of Veeva RIM system

The annual base salary (or hourly wage) for this position falls within the range of $171,000.00 - $230,850.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.