Manager, CMC Regulatory Affairs – Global Rare Diseases

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Chiesi Group

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.

📋 Description

• Maintain or create CMC regulatory documents for product submissions • Manage CMC regulatory documents in collaboration with the Core team • Advise project teams on regulatory agency requirements • Review change control requests pertaining to CMC aspects • Agree on regulatory strategy for GRD products' life cycle • Maintain submission information and track commitments • Work with external CMOs and cross-functional teams • Support development of processes and Standard Operating Procedures • Represent GRDRA during GMP inspections • Keep abreast of current regulatory CMC requirements

🎯 Requirements

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred • 5+ years of Regulatory CMC experience • Advanced knowledge of current global CMC regulations, including ICH and regulatory requirements • Sound knowledge of manufacturing technical transfer and comparability regulatory requirements • Experience in authoring technical documents, CTD M2 and M3 sections • Proficient in the use of quality management software (e.g. TrackWise) • Strong attention to detail • Ability to multi-task and prioritize • Strong communication skills (oral, written, and interpersonal) • Ability to work independently and in a group setting

🏖️ Benefits

• Annual bonus scheme • Comprehensive benefits package including pension • Private medical insurance • Wellbeing programme • Flexible benefits programme