Associate Director Regulatory Affairs (Labeling) FSP

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose

Are you ready to join a world-class team at Thermo Fisher Scientific Inc. As the Associate Director of Regulatory Affairs (Labeling) FSP you will manage global labeling activities. You will ensure compliance with international regulatory standards. This outstanding opportunity lets you coordinate labeling processes across foundational and dependent markets. You will apply your organizational technical and regulatory expertise to manage complex global labeling operations flawlessly.

Responsibilities

• Labeling Coordination & Management

Coordinate readability testing translations and linguistic reviews for foundational markets (EU CH DE).

1. Manage the preparation review and upload of approved labels to internal systems (Documentum Weblabel intranet) and external platforms (HA ePIL).

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

1. Coordinate data entry for labeling systems (Trackwise Veeva) and maintain labeling records.

Maintain and update Company Core Data Sheet (CCDS) US Prescribing Information (USPI) and EU Summary of Product Characteristics (SmPC).

• Governance & Compliance

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

1. Prepare materials for Labeling Review Committee (LRC) and Global Labeling Committee (GLC) making sure records of decisions and minutes are accurate.

Manage global labeling compliance activities including quality control FDA-508 compliance and annual reporting requirements (US drug listing and NDC assignments).

1. Manage impact analyses for technical and global labeling changes.

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

• Regulatory & Cross-Functional Support

Prepare change control documentation and deviation reports for foundational and non-foundational markets.

1. Manage Health Authority (HA) requests RFIs and label negotiations.

Provide regulatory assistance for advertising promotion and medical education materials to ensure alignment with approved labeling and regional requirements.

1. Collaborate with Medical Affairs Legal and Commercial teams to review and approve promotional and non-promotional materials.

Manage Standard Operating Procedures (SOPs) and electronic review systems related to labeling and promotional review.

1. Provide strategic input to therapeutic area teams and influence external labeling landscapes through competitive intelligence and regulatory insight.

Act as key partner to GRA Regions Regulatory CMC and Supply Chain to ensure accurate and timely implementation of labeling decisions.

Qualifications

• A minimum of 10 years working in the biotech or pharmaceutical sector including more than 2 years dedicated to labeling.
• Demonstrated experience leading teams and initiatives in a matrixed organizational structure.
• Comprehensive understanding of worldwide labeling lifecycle management and regulatory demands for US EU DE CH and AU markets.
• Established skill in handling numerous challenging projects under pressing deadlines.
• Experience reviewing technical and scientific documents and influencing cross-functional teams.
• Familiarity with labeling for flu campaigns pandemic products and promotional material compliance.
• Experience with CTA submissions and coordination of global regulatory documentation preferred.

Education and Experience

• Education: Bachelors degree or equivalent experience (4-year degree) in Life Sciences Chemistry Engineering or a related Pharmaceutical field.
• Preferred: Advanced degree (MSc PhD or equivalent experience or PharmD).
• Experience: At least 10 years in the biotech or pharmaceutical field including a minimum of 2 years in regulatory labeling and over 5 years managing teams; Demonstrated leadership abilities

Technical Skills

• Proficient with regulatory and document management systems including:

RIMS: Veeva RIMS

1. eDMS: Veeva Apollo Docubridge

Change Management: Trackwise

1. Other Tools: Microsoft Office Suite SharePoint Adobe Acrobat TVT Promomats GLAMS

• Knowledge of Structured Product Labeling (SPL) preparation and submission or equivalent experience.
• Understanding of FDA-508 compliance and digital labeling requirements.
• Experience with electronic promotional review and approval systems (e.g. Promomats) and CTA submission platforms.

Proficiencies

• Demonstrated ability to act as a labeling strategist and inspiring leader within Global Regulatory Affairs.
• Strong understanding of regulatory requirements relevant to global drug development labeling and post-marketing obligations.
• Strong analytical and problem-solving abilities capable of evaluating risks and suggesting appropriate solutions.
• Cross-functional collaboration and communication skills with proven success working in culturally diverse global teams.
• Outstanding organizational abilities to prioritize various tasks and ensure adherence to regulatory standards.
• Strategic and diligent thinking with the ability to influence and communicate complex concepts clearly.
• Proficient in English (verbal and written); additional languages are an asset.