Manager, CMC Regulatory Affairs – Global Rare Diseases

Chiesi Group

Seeking Regulatory Affairs Manager with CMC experience for Chiesi's Global Rare Diseases unit. Responsible for regulatory documents and submissions for product approvals.

Posted 7/4/2026full-timeRemote • 🇮🇹 ItalyMid-LevelSenior💰 €46,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory CMC processes, including the creation and management of regulatory documents, adherence to global CMC regulations, and effective collaboration with cross-functional teams. Proficient in authoring technical documents and maintaining compliance during GMP inspections.

Highest-signal resume keywords

Regulatory CMC ExperienceGlobal CMC RegulationsTechnical Document AuthoringQuality Management SoftwareStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document ManagementCMC Regulatory RequirementsTechnical Transfer KnowledgeCTD M2 and M3 AuthoringGMP Compliance

Soft Skills

Attention to DetailMulti-taskingPrioritizationInterpersonal Skills

Tools & Technologies

TrackWise

Industry Keywords

ICH GuidelinesRegulatory StrategyChange ControlStandard Operating ProceduresGMP Inspections

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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