Canada - Associate Director, Global RA Labeling Lead

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 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 scien