Associate Director, Global Ra Labeling Lead

About Freyr

Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.

Job Title: Associate Director, Global RA Labeling Lead

Job Type: Permanent

Job Location: Princeton, NJ - Remote

Job Description

Role Overview:

The Associate Director, Global RA Labeling Lead will be a key member of the Global Regulatory Labeling function supporting Plasma-Derived Therapies (PDT). The role is responsible for providing regulatory expertise, strategic insight, and guidance to cross-functional stakeholders to ensure the successful development and lifecycle management of global product labeling.

The position will lead labeling strategy across development and marketed products, working closely with Clinical, Pharmacovigilance, Legal, Scientific, Commercial, Regulatory Affairs, and other stakeholders. The role requires strong knowledge of global labeling requirements, particularly US and EU regulations, and the ability to lead complex, cross-functional initiatives in a global environment.

Key Responsibilities

• Drive global labeling strategy through the development and lifecycle management of Company Core Data Sheets (CCDS), US labeling, and EU labeling.
• Formulate and implement innovative regulatory strategies for labeling development to support commercialization of developmental products, marketed products, and global expansion.
• Develop strategic labeling plans for early development programs and obtain alignment from internal stakeholders.
• Leverage labeling precedents, Health Authority feedback, and regulatory guidance to develop effective labeling strategies.
• Provide regulatory guidance on combination product and drug-device labeling.
• Interpret scientific and clinical data and lead the development of labeling strategies that optimize product potential and patient benefit-risk.
• Develop innovative approaches for data presentation and obtain consensus across labeling teams while meeting Health Authority requirements.
• Develop contingency and backup strategies to support labeling negotiations.
• Lead global labeling teams and cross-functional labeling projects.
• Lead CCDS, US, and EU labeling teams in the development and maintenance of product labeling.
• Engage cross-functional stakeholders to establish consensus on labeling strategy and resolve conflicts or issues with minimal escalation.
• Partner with Regulatory Intelligence teams to maintain awareness of regulatory legislation and guidance affecting labeling and communicate relevant impacts to products.
• Provide guidance to Regulatory Affairs affiliates in assessing labeling changes and ensuring timely implementation.
• Oversee labeling processes, templates, tools, and systems to improve efficiency, productivity, quality, consistency, and regulatory compliance.
• Project manage new and updated labeling activities to meet internal and Health Authority submission timelines.
• Manage and facilitate review of CCDS and regional labeling through appropriate labeling teams and governance committees.
• Prepare final proposed labeling for review and approval prior to internal approval and/or submission to Health Authorities.
• Manage preparation of submission-ready labeling components and consult with affiliates regarding Health Authority communications.
• Ensure internal and external stakeholders are informed of proposed and newly approved labeling changes, as required.
• Ensure compliant version control of product labeling and related documentation within document management systems.
• Ensure quality control of CCDS and other labeling documents.
• Maintain labeling decision records and ensure appropriate tracking and archiving of labeling history.
• Support employee awareness and adherence to labeling processes through regulatory training.
• Design and deliver labeling training programs.
• Maintain end-to-end labeling tracking information to support compliance and oversight of labeling activities.

Qualifications and Experience

• Minimum of 7–10 years of experience in the biopharmaceutical industry , including areas such as Regulatory Affairs, regulatory strategy, safety, medical affairs, advertising/promotion, or related functions.
• 5–7 years of direct experience in a global, US, or EU labeling role is preferred.
• Experience with plasma-derived therapies and biologics is preferred.
• Bachelor's or Master's degree required;
  an advanced scientific or health sciences degree is preferred.
• Previous leadership experience and experience managing direct reports preferred.
• Detailed understanding of pharmaceutical drug and device development and global regulations related to labeling.
• Strong knowledge of US and EU labeling requirements and regulatory guidance .
• Knowledge of combination product/drug-device labeling preferred.
• Advertising and promotion experience is a plus.
• Expertise in the development and maintenance of:
• Company Core Data Sheet (CCDS)
• US Prescribing Information (USPI)
• EU Summary of Product Characteristics (EU SmPC)
• Understanding of Structured Product Labeling (SPL) format, requirements, and guidance for legacy and PLR labels.
• Proficiency with Electronic Document Management Systems (EDMS) and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Leadership & Stakeholder Management

• Ability to motivate, mentor, and manage diverse cross-functional teams.
• Demonstrated ability to work effectively across functions, regions, and cultures.
• Strong collaboration and stakeholder management skills with the ability to build credibility and confidence.
• Ability to influence senior stakeholders without direct authority.
• Strong communication skills, both verbal and written.
• Ability to identify challenges and opportunities and make sound recommendations.
• Experience building strategic, cross-functional stakeholder relationships.
• Ability to interview, mentor, and develop employees and consultants.
• Demonstrated ability to manage change and operate effectively within a global, highly matrixed organization.

Decision-Making & Autonomy

• Ability to make sound decisions and exercise judgment with limited information.
• Ability to develop clear business arguments and strategic recommendations using quantitative and qualitative evidence.
• Ability to balance input from multiple internal and external stakeholders to drive solutions and establish priorities.
• Ability to incorporate feedback and make timely decisions to support effective execution.
• Strong project planning skills with the ability to meet budgets and deadlines.
• Data-driven approach to decision-making.
• Ability to challenge existing approaches, overcome barriers, and deliver high-quality solutions.
• Demonstrated initiative and ability to advance strategic projects with minimal guidance.
• Comfortable making decisions in complex and ambiguous situations.

Innovation & Problem Solving

• Ability to develop innovative solutions to complex regulatory and labeling challenges.
• Continuously challenge the status quo and identify opportunities for process improvement.
• Ability to identify opportunities for systems and process innovation and implement changes that improve team effectiveness.
• Ability to solve complex problems across multiple functional areas.
• Ability to simplify complex issues involving commercial, operational, regulatory, and strategic considerations.
• Resilient and comfortable working through large-scale global change.
• Strong understanding of the global drug discovery and development process and regulations affecting biopharmaceutical development across US, EU, and international markets.

Core Competencies

• Global Regulatory Affairs
• Regulatory Labeling Strategy
• Global Labeling
• CCDS Development & Maintenance
• USPI / US Labeling
• EU SmPC / EU Labeling
• Health Authority Regulations & Guidance
• Combination Product / Drug-Device Labeling
• Labeling Lifecycle Management
• Regulatory Strategy
• Labeling Governance
• Cross-Functional Leadership
• Stakeholder Management
• Regulatory Intelligence
• Labeling Negotiations
• SPL
• EDMS
• E2E Labeling Tracking
• Quality Control & Compliance
• Regulatory Training

What We Offer

• Opportunity to work on complex global Regulatory Affairs and labeling programs.
• Exposure to global pharmaceutical and biotechnology regulatory environments.
• Collaboration with experienced regulatory and life sciences professionals.
• Opportunities for professional development and career growth.
• A global and cross-functional working environment.
• Opportunity to contribute to innovative labeling strategies supporting product development, commercialization, and lifecycle management.

Why Join Freyr

• Be part of a global Life Sciences and Regulatory Solutions organization.
• Work on challenging regulatory and global labeling programs across pharmaceutical and biotechnology organizations.
• Gain exposure to global labeling strategies, CCDS, USPI, EU SmPC, and Health Authority requirements.
• Work with multidisciplinary teams across Regulatory Affairs, Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other functions.
• Build expertise across global labeling requirements and product lifecycle management.
• Grow your career in a collaborative and innovation-driven environment.

Equal Opportunity Employer

Freyr is committed to providing equal employment opportunities and fostering an inclusive workplace where diverse perspectives are valued. We provide opportunities based on qualifications, experience, skills, and business requirements.