Director Regulatory Affairs (Labeling)- FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose

As the Director Regulatory Affairs (Labeling) - FSP at Thermo Fisher Scientific Inc., you will play a pivotal role in our mission to deliver world-class regulatory labeling excellence. This is an outstanding opportunity for a proven leader to build global labeling strategies and ensure flawless compliance with international regulatory standards. You will coordinate labeling processes across global markets, applying your expertise in regulatory affairs to successfully implement innovative solutions.

Responsibilities

• Labeling Coordination & Management

Coordinate readability testing, translations, and linguistic reviews for foundational markets.

1. Manage the preparation, review, and upload of approved labels to internal and external platforms.

Dispatch CCDS and multi-market manuscripts to dependent markets and collaborators.

1. Coordinate data entry for labeling systems and maintain accurate labeling records.

Maintain and update critical labeling documents such as CCDS, USPI, and SmPC.

1. Lead Global Labeling Committee assessments and manage regional label exceptions.

• Governance & Compliance

Support the creation of label content, including DLS or equivalent experience and CCDS documentation.

1. Prepare materials for Labeling Review Committee and ensure accurate record-keeping.

Manage global labeling compliance activities, including quality control and annual reporting.

1. Coordinate impact assessments for technical and global labeling changes.

Ensure adherence to country-specific regulatory requirements for labeling and submissions.

• Regulatory & Cross-Functional Support

Prepare change control documentation and manage Health Authority requests.

1. Provide regulatory support for advertising and promotional materials to ensure compliance.

Collaborate with Medical Affairs, Legal, and Commercial teams for material reviews.

1. Manage SOPs and electronic review systems related to labeling.

Provide strategic input to therapeutic area teams and influence external labeling landscapes.

• Clinical Trial Regulatory Responsibilities

Develop and coordinate global Clinical Trial Authorization submission strategies.

1. Act as the regulatory interface between labeling, clinical operations, and health authorities.

Ensure adherence to regional regulatory requirements.

• Operational & Administrative Activities

Maintain multi-market manuscripts and master artwork files.

1. Coordinate administrative labeling updates for various markets.

Prepare annual strain update labeling for both hemispheres.

1. Participate in GRAST meetings and bi-weekly GL Leadership updates.

Qualifications

• 12+ years of experience, including 5+ years in a management role.
• Proven leadership in a matrixed organizational structure.
• In-depth knowledge of global labeling lifecycle management.
• Demonstrated ability to manage complex projects under tight deadlines.
• Experience with CTA submissions and global regulatory documentation.
• Education: Bachelor’s degree or equivalent experience in Life Sciences, Chemistry, Engineering, or related field; Advanced degree preferred.

Technical Skills

• Proficient with regulatory and document management systems such as Veeva RIMS, Trackwise, and others.
• Knowledge of Structured Product Labeling preparation and submission.
• Understanding of FDA-508 compliance and digital labeling requirements.

Proficiencies

• Strong strategic and analytical skills.
• Effective cross-functional collaboration and communication abilities.
• Outstanding organizational skills and attention to detail.
• Proficient in English; additional languages are an asset.