Senior Manager Regulatory Affairs

Senior Manager Regulatory CMC (NCE / ADC Linkers) – Hybrid -Location: Germany

We are seeking an experienced

Regulatory CMC professional

to lead global Regulatory CMC activities for

New Chemical Entities (NCEs)

and

chemically synthesized drug-linkers for Antibody Drug Conjugates (ADCs)

across all clinical phases through to first registration, launch, and post-approval lifecycle.

This role sits at the interface of

Global Regulatory Affairs and CMC technical functions , with full ownership of Regulatory CMC strategy and CMC dossier content for global submissions.

Key Responsibilities Lead and define the

global Regulatory CMC strategy

for clinical development, registration, and lifecycle management Author, review, and approve CMC sections for

IND, IMPD, NDA, MAA , Scientific Advice, and responses to Health Authority questions Act as the primary liaison between Regulatory Affairs and CMC technical teams (drug substance, drug product, analytical development) Translate global regulatory requirements into actionable CMC development plans Represent Regulatory CMC in global project teams and Health Authority interactions Support

due diligence activities

for in- and out-licensing projects

Requirements Degree in pharmacy, chemistry, or life sciences (PhD advantageous) Minimum 5 years’ experience in the pharmaceutical industry or Health Authorities At least 3 years of experience specifically in

Regulatory CMC Experience with

NCEs

and/or

ADC drug-linkers Strong experience authoring and managing CMC dossiers Solid knowledge of global CMC regulatory requirements (EU, US, and other regions) Excellent communication skills and ability to work cross-functionally

What We Offer Hybrid working model Opportunity to work on innovative molecules in Oncology, Neurology, and Fertility High visibility role within global regulatory and CMC project teams Collaborative, international, and science-driven environment