Regulatory CMC Specialist - Via Milano - Discover International

Descrizione

About the Role

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We are seeking a highly motivated

Regulatory Affairs CMC Specialist

to support global regulatory activities for an innovative

gene therapy product

in

clinical development (Phase I–III)

.
The successful candidate will contribute to the preparation and lifecycle management of

CMC regulatory documentation

, ensuring compliance with EU and global regulatory requirements for advanced therapies (ATMPs).

Key Responsibilities

CMC Regulatory Strategy & Execution
Support the development and implementation of

global CMC regulatory strategies

for gene therapy products in clinical phases
Contribute to

regulatory submission planning

, including IND/IMPD, CTA, BLA/MAA components (CMC sections)
Ensure alignment of CMC documentation with current regulatory guidelines (EMA, FDA, ICH)

Regulatory Submissions
Prepare, review, and compile

Module 3 (Quality) sections

of regulatory dossiers

Support submission of:
Clinical Trial Applications (CTA) / INDs / IMPDs
Scientific Advice / Regulatory briefing packages
Amendments, variations, and annual reports
Coordinate responses to

health authority questions

related to CMC

CMC Documentation & Compliance
Ensure

consistency and accuracy

of CMC data across regulatory submissions

Maintain oversight of:
Drug substance and drug product information
Manufacturing processes (viral vectors, cell banks)
Analytical methods and specifications
Stability data and comparability studies
Track and assess

CMC changes

and their regulatory impact

Cross-functional Collaboration
Interface with

CMC, Quality, Manufacturing, and Clinical teams
Support interactions with

CMOs/CDMOs
Contribute to

regulatory intelligence activities

for ATMPs

Health Authority Interactions
Assist in preparation for

meetings with regulatory agencies

(EMA, national agencies, FDA)
Support documentation for

Scientific Advice and Paediatric Investigation Plans (PIPs)

where applicable

Qualifications
Master's or PhD in

Life Sciences, Pharmacy, Biotechnology, or related field

Experience xkiyazw
3–6 years of experience in

Regulatory Affairs CMC
Experience with

biologics or advanced therapies (gene therapy, cell therapy, viral vectors)
Experience supporting

clinical-stage regulatory submissions

Technical Skills

Strong knowledge of:
CMC requirements for biologics/ATMPs
ICH guidelines (Q5, Q6, Q8–Q12)
EU Clinical Trial Regulation (CTR)
Familiarity with eCTD format and submission system

s

Preferred Qualifications
Experience with

AAV, lentiviral vectors, or other gene delivery platforms
Experience with

comparability exercises

and process changes
Prior interaction with

EMA or national competent authorities
Knowledge of

GMP requirements for ATMPs