Regulatory Affairs - Global Labeling Lead

Talentify; Mississauga; Remote; CAD 100,000 - 125,000; Full time

Job summary

A leading company in the regulatory affairs sector is seeking a Global Labeling Specialist. This fully remote role involves managing the lifecycle of product labeling documents and ensuring compliance with global regulations. The ideal candidate will demonstrate strong leadership and communication skills, along with a deep understanding of regulatory requirements.

Qualifications

• Proven experience in regulatory affairs focusing on labeling.
• Strong understanding of global regulatory labeling requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Develop and maintain core labeling documents and manage their lifecycle.
• Ensure compliance with global regulatory requirements for product labeling.
• Lead Labeling Teams and facilitate decision-making.

Skills

Regulatory Affairs

Labeling Strategy & Compliance

Cross-functional Leadership

Analytical Skills

Problem-solving Skills

Tools

Labeling systems

Document management tools

Job description

Job Description

We are seeking a highly skilled and proactive Global Labeling Specialist to join our Regulatory Affairs team. The ideal candidate will have deep expertise in global labeling processes, regulatory requirements, and cross-functional collaboration to support the development and lifecycle management of product labeling documents.

Key Responsibilities

1. Develop, update, and maintain core labeling documents (CCDS, USPI, SmPC) and manage their global lifecycle and downstream implementation.
2. Lead and optimize global labeling processes, including SOPs, work instructions, training materials, and workshops.
3. Ensure compliance with global regulatory requirements for product labeling.
4. Drive alignment across regulatory, medical, clinical, and other departments to define and execute labeling strategies.
5. Lead Labeling Teams, Review Committees, and Strategy Teams to facilitate decision-making.
6. Proactively identify and resolve regulatory and labeling challenges.
7. Implement labeling changes and ensure compliance throughout downstream processes.
8. Manage multiple labeling projects simultaneously, ensuring timely and quality delivery.
9. Anticipate potential labeling issues and implement effective risk mitigation strategies.
10. Prepare high-quality labeling justifications and responses to health authorities.
11. Translate complex regulatory and scientific data into clear, actionable labeling content.
12. Assess clinical data and safety updates for labeling impact.
13. Utilize labeling tools, tracking systems, and document management platforms effectively.
14. Communicate label update plans to Hub Labeling Managers in a timely and efficient manner.
15. Champion continuous improvement initiatives in collaboration with Labeling Operations Managers and Regulatory Strategists.

Required Skills & Qualifications

• Proven experience in regulatory affairs with a focus on labeling.
• Strong understanding of global regulatory labeling requirements.
• Excellent written and verbal communication skills.
• Demonstrated leadership in cross-functional teams and labeling committees.
• Experience with labeling systems and document management tools.
• Strong analytical and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience in pharmaceutical or biotechnology industries.
• Familiarity with global health authority regulations and submission processes.

Top Skills

• Regulatory Affairs
• Labeling Strategy & Compliance
• Cross-functional Leadership

Pay and Benefits

The pay range for this position is $45.00 - $50.00/hr.

Workplace Type

This is a fully remote position.