Regulatory Labeling Associate Director

Job not on LinkedIn

🔥 13 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $161.6k - $242.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Execute strategic labeling for one or more products at the global label level or across multiple ROW countries/regions • Ensure compliance with labeling governance requirements and associated business processes • Lead label working groups • Represent labeling at senior labeling governance meetings • Develop and maintain global product labeling, including company core datasheets, major-market labels, ROW market-specific labels, packaging components, and target label profiles • Contribute to labeling strategy • Advise stakeholders on regulatory labeling requirements for quality, preclinical, and clinical data • Oversee health authority interactions regarding labeling across products or ROW markets • Manage responses to questions, negotiations, and inspections • Potentially take responsibility for specific business processes • Potentially develop and manage a TLP with guidance

🎯 Requirements

• Bachelor’s degree, preferably in a life sciences field • Typically 8 years of experience in regulatory affairs in global labeling or a related discipline, or equivalent combination of education and experience • Specialized knowledge of global labeling requirements • Knowledge of development and life-cycle management of CCDS • Knowledge of global regulatory authorities, including FDA and EMA; may include Health Canada and TGA • Advanced ability to develop, use, and apply regulatory global and/or regional labeling frameworks • Advanced ability to plan, prioritize, lead, and execute regulatory labeling work, teamwork, and projects • Strong understanding of labeling compliance and operational requirements • Ability to adopt and leverage emerging technologies, including AI-driven tools • Continuous learning mindset and awareness of technology, AI, automation, competitive intelligence, and regulatory changes

🏖️ Benefits

• Annual bonus eligibility • Annual equity awards • Medical benefits • Dental benefits • Vision benefits • Generous paid time off • Week-long company shutdown in the Summer • Week-long company shutdown in the Winter • Educational assistance programs • Student loan repayment • Commuting subsidy • Matching charitable donations • 401(k) • Remote work five days per week option • Hybrid work option • On-site work option with ad hoc flexibility