Senior Regulatory Affairs CMC Consultant

Excelya

. Lead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate (ADC) programs .

Posted 10/6/2026full-timeRemote • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global Regulatory CMC strategies for biologics and Antibody Drug Conjugate (ADC) programs, with a strong focus on BLA and MAA submissions, regulatory compliance, and cross-functional collaboration.

Highest-signal resume keywords

Regulatory CMC StrategyBiologics ExpertiseModule 3 Submission LeadershipICH, FDA, EMA ComplianceGlobal Regulatory Strategy Implementation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMCBLA SubmissionMAA SubmissionModule 3 PreparationRegulatory Risk MitigationSubmission Documentation QualityLifecycle ManagementCross-Functional CollaborationRegulatory Question CoordinationScientific Consistency

Soft Skills

Strategic LeadershipProactive Problem SolvingEffective CommunicationCollaboration

Industry Keywords

BiologicsAntibody Drug ConjugatePharmaceutical IndustryRegulatory ComplianceGlobal Health AuthoritiesFDAEMAICHPharmacyLife Sciences

About the role

Key responsibilities & impact

Lead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate (ADC) programs
Provide strategic leadership for global BLA and MAA preparation, submission, and lifecycle management activities
Align CMC regulatory strategies with overall product development and commercialization objectives
Anticipate regulatory risks and develop proactive mitigation plans
Oversee preparation, review, and finalization of Module 3 CMC content for global submissions
Ensure scientific consistency, regulatory compliance, and quality of submission documentation
Lead interactions with global health authorities, including FDA, EMA, and other international agencies, on CMC-related topics
Coordinate responses to regulatory questions, deficiency letters, and agency requests
Drive cross-functional collaboration within a global matrix environment
Maintain expertise in ICH, FDA, EMA, and international regulatory requirements supporting registration and lifecycle management of biologic and ADC products

Requirements

What you’ll need

Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline
Solid experience in Regulatory CMC within the pharmaceutical industry
Strong expertise in biologics products
Proven hands-on experience leading Module 3 of biologic MAA and/or BLA submissions
Understanding of ICH, FDA, and EMA regulatory requirements applicable to Module 3
Demonstrated experience defining and implementing global regulatory strategies
Fluent English required

Benefits

Comp & perks

International network and collaboration opportunities
Talent development and skills-building opportunities
Opportunity to work on a wide variety of high-value healthcare projects
Collaboration with recognized experts
Meaningful contribution to improving the patient journey
Equal-opportunity, diverse, equitable, and inclusive working environment
Employee experience focus