Senior Regulatory Affairs Manager

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November 19

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Coordinate readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE) • 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, stakeholders, and partners • Oversee and perform 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) • Lead Global Labeling Committee (GLC) assessments and manage exceptions between CCDS and regional labels • Support label content creation, including development of DLS and CCDS documentation • Prepare materials for Labeling Review Committee (LRC) and Global Labeling Committee (GLC), ensuring accurate record-keeping of decisions and minutes • Manage global labeling compliance activities, including quality control, FDA-508 compliance, and annual reporting requirements (US drug listing and NDC assignments) • Coordinate impact assessments for technical and global labeling changes • Ensure compliance with country-specific regulatory requirements for labeling, submissions, and artwork approvals • Prepare change control documentation and deviation reports for foundational and non-foundational markets • Manage Health Authority (HA) requests, RFIs, and label negotiations • Provide regulatory support for advertising, promotion, and medical education materials to ensure compliance with approved labeling and regional requirements • 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 • 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 • Develop and oversee global Clinical Trial Authorization (CTA) submission strategy • Act as the regulatory interface between labeling, clinical operations, and global health authorities • Ensure compliance with EU Clinical Trial Regulation (CTR) and other regional regulatory requirements • Maintain multi-market manuscripts and master artwork files • Coordinate administrative labeling updates (e.g., address or Windsor updates) for EU and other markets • Prepare annual strain update labeling (Northern and Southern Hemispheres) • Participate in GRAST meetings and GL Leadership bi-weekly updates

🎯 Requirements

• Minimum of ## years of experience in the biotech or pharmaceutical industry, including 5 + years in labeling • Demonstrated experience leading teams and initiatives in a matrixed organizational structure • In-depth knowledge of global labeling lifecycle management and regulatory requirements for US, EU, DE, CH, and AU markets • Proven ability to manage multiple complex projects under tight 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: Bachelor’s degree (4-year degree) in Life Sciences, Chemistry, Engineering, or a related Pharmaceutical field • Preferred: Advanced degree (MSc, PhD, or PharmD).

🏖️ Benefits

• EEO Thermo Fisher Scientific is an Equal Opportunity Employer • Accessibility/Disability Access