Regulatory CMC Technical Lead Consultant

🔥 0 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.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.

Apply Now

Find Similar Remote Jobs

ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Maintain or create CMC regulatory documents for dedicated products to support submissions to Regulatory Authorities • Manage CMC regulatory documents in collaboration with the Core team, with full responsibility and no supervision • Act as the CMC representative at core team level with a global role, where required • Author and/or review CMC sections for new marketing authorization applications, investigational applications, and variations/supplements worldwide • Advise multidisciplinary project teams on regulatory agency requirements and expectations for CMC submission dossier sections • Review and assess change control requests relating to CMC aspects of products • Agree on regulatory strategy for product life cycle and development with CMC functions • Maintain submission information in the document management system and track regulatory CMC commitments and timelines with minimal supervision • Collaborate with external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer activities • Negotiate strategies and actions with regulatory agencies on CMC submission dossier sections • Support process development and preparation of Standard Operating Procedures • Support due diligence activities on CMC regulatory documents • Represent the company during GMP inspections by regulatory agencies, where required • Maintain knowledge of regulations, policies, guidelines, and evolving regulatory CMC requirements

🎯 Requirements

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline • Minimum of 5 years of experience in Regulatory CMC focusing on small molecule drug development • Additional experience with biologics and Antibody-Drug Conjugates (ADCs) is highly desirable and considered a strong advantage • Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements • Sound knowledge of manufacturing technical transfer and comparability regulatory requirements • Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations • Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system • Strong attention to detail • Ability to multi-task, stay organized and prioritize • Strong communication skills (oral, written and interpersonal) • Critical thinking and ability to identify and recommend solutions to problems • Ability to work independently and in a group setting • Ability to thrive in a fast-paced environment

🏖️ Benefits

• Continuous training and professional development • Equal opportunity employer • Diversity and inclusivity-focused workplace

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume