Regulatory CMC Technical Lead Consultant

ClinChoice

. Maintain or create CMC regulatory documents for dedicated products to support submissions to Regulatory Authorities .

Posted 11/4/2026full-timeRemote • ItalySeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in CMC regulatory documentation and submission processes, with a strong focus on small molecule drug development and compliance with global regulations. Capable of collaborating with cross-functional teams and external partners to optimize processes and ensure adherence to regulatory requirements.

Highest-signal resume keywords

Regulatory CMC ExperienceGlobal CMC Regulations KnowledgeTechnical Document AuthoringQuality Management Software ProficiencyStrong Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

CMC Regulatory DocumentationSmall Molecule Drug DevelopmentTechnical Document AuthoringCTD M2 and M3 SectionsRegulatory Submission StrategyChange Control AssessmentGMP Inspection RepresentationRegulatory Agency NegotiationProcess Development SupportLife Cycle Management

Soft Skills

Attention to DetailOrganizational SkillsCritical ThinkingProblem-SolvingAbility to Multi-Task

Tools & Technologies

Quality Management SoftwareTrackWiseRegulatory Document Management System

Industry Keywords

ICH RequirementsUS/EU Regulatory RequirementsManufacturing Technical TransferComparability Regulatory RequirementsAntibody-Drug Conjugates (ADCs)

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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