CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

🔥 18 minutes ago

🌐 Mexico, Argentina, +1 more countries – Remote

🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 10%

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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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Conduct and deliver high-quality, on-time CMC regulatory activities, including compliant management of internal tools and client systems • Author administrative and CMC regulatory documents and deliverables • Collaborate with project SMEs and client stakeholders to prepare submission packages • Manage CMC submissions, including planning, submission package compilation, RtQ preparation, and responses to spontaneous Health Authority queries • Coordinate submissions by updating trackers, agreeing timelines with LRAs and GRA-CMC, and attending recurring meetings with LRAs • Create submission binders and Global Content Lists/Submission Content Plans • Coordinate publishing activities and review eCTD sequences • Act as the main GRA point of contact for LRAs and other stakeholders • Coordinate all assigned activities • Ensure compliance with client SOPs and training sessions • Support regulatory strategies and successful submissions contributing to medical advancements

🎯 Requirements

• University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD) • Degree in Regulatory Affairs is advantageous • Minimum of 5 years’ experience in the biotech or pharmaceutical industry • At least 5 years in Regulatory Affairs CMC for Senior level and 2 years for Associate level • Experience with biological products (mandatory) • Experience with vaccines (preferable) • M3 authoring experience (mandatory) • Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia) • Regulatory CMC writing skills and ability to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements • Knowledge of Good Manufacturing Practice or related areas highly regarded • Experience using Veeva • Excellent communication and stakeholder management skills • Strong organizational and time management skills • Strong problem-solving skills • Strong oral and interpersonal skills • Proven ability to work efficiently as part of a team • Ability to comply with client SOPs and training requirements

🏖️ Benefits

• Opportunities for growth and impact within a collaborative and forward-thinking team environment