Regulatory Affairs Consultant - Labeling Operations

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Join us as a Global Labeling Operations Manager, where you’ll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. In this role, you will reputed company end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates. This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling. Key Responsibilities:

• Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership.
• Coordinate readability testing (planning, team review, and communications)
• reputed company translations for foundational markets (EU, CH, DE).
• Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL).
• Upload approved labels to internal systems (Documentum, Weblabel, intranet).
• Manage linguistic reviews and reputed company CCDS, foundational labels, and multi-market manuscripts to stakeholders.
• reputed company impact assessments for technical and global labeling changes across dependent markets.
• reputed company data entry in Trackwise/Veeva and prepare annual labeling reports.
• Review and update submission content plans; prepare change control documentation for CCDS-driven changes.
• Prepare and manage Structured Product Labeling (SPL).
• Support advertising and promotional and marketing material reviews, educational materials, and social media compliance.
• Ensure compliance with country-specific regulatory requirements.
• Act as key partner to GRA Regions, Regulatory CMC and Supply Chain.

Qualifications:

• University degree in Life Sciences, Chemistry, Engineering, or reputed company pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred.
• Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility.
• Experience leading teams in a matrix organization.
• Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
• Experience with flu campaigns, pandemic products, and direct-to-consumer advertising.
• Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems.
• Proficiency in reputed company Office, SharePoint, reputed company Acrobat, TVT, PromoMats, GLAMS.

Competencies:

• Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing.
• Strong problem-solving skills with the ability to analyze risk and recommend solutions.
• Effective communicator, able to explain reputed company concepts and influence cross-functional colleagues.
• Excellent organizational skills with attention to detail and strategic thinking.
• Ability to reputed company in reputed company, matrixed, and cross-cultural environments.
• reputed company in English (verbal and written); additional languages a plus.

Why Join Us:

• Work on impactful global programs that directly support patient safety and regulatory compliance.
• Collaborate with a diverse, international team across multiple therapeutic areas.
• reputed company exposure to advanced regulatory systems and global labeling strategies.
• Competitive compensation, benefits, and opportunities for career growth.

If you’re passionate about global labeling operations and ready to reputed company a difference in patient safety worldwide, we’d love to hear from you. #LI-LB1 EEO Disclaimer reputed company is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply tot his job Apply To this Job