Global Regulatory Affairs CMC Manager (m/w/d)

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Bern, Schweiz |

Temporary Employment

Job title: Global Regulatory Affairs CMC Manager (m/w/d)

Industry: Biotech
Skills: Regulatory Affairs, CMC, Module 3

Start of project: 01.11.2023

Duration of the project : 12 months

Location: Bern

Tasks:

Responsible for operational regulatory CMC activities such as:
Coordination, preparation and review of regulatory submission packages related to CMC submissions and Health Authority responses for the Gene Therapy portfolio.
Supports scheduling and prioritization of CMC related submissions.
Responsible for the compilation and maintenance of CMC documentation/CTD for regulatory submissions and cooperation with relevant technical expert departments in cross-functional teams.
Responsible for regulatory CMC documents/CTD documentation formatting and maintenance within document management system, maintenance of relevant regulatory lists and tracking documents.
Provision or support of timely and compliant regulatory assessments, as well as efficient execution of CMC changes.
Evaluates available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.

Qualifications:

Referenznummer:

Branche:

Beginn des Projekts:

Dauer:

Anstellungsart:

Kontakt

Lars Uhl

13619

Biotech

01.11.2023

12 months

Temporary Employment