Job Description

For our headquarters in Munich we are seeking highly qualified candidates to fill the position:





Associate (m/f/x) CMC Regulatory Affairs

- fixed-term (1 year) -





The Position:



Within Daiichi-Sankyo’s Technology Unit, the role of the Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) function is to lead the preparation of dossiers on manufacturing and testing of Daiichi-Sankyo’s development and commercial products across the whole portfolio, and to submit to international health authorities. To ensure high quality standards and latest health authority expectations are met in our dossiers, we are both closely interacting with research laboratory or manufacturing functions within Daiichi Sankyo, and also aiming to maintain a trustful relationship with the health authorities, striving to ensure on-time approval of our drugs and securing patient supply. Within the EU RACMC Team, the role of the Associate CMC Regulatory Affairs will provide regulatory operational support for development and commercial products of all modalities (i.e. biologics and small molecule portfolio). The role will be embedded in RACMC product teams and is supporting to ensure timely and accurate CMC regulatory product management and compliance of supported projects, meeting overall project objectives.





Roles and Responsibilities:

Authoring of CMC

documentation:

Operative support of authoring activities for CMC regulatory documentation and dossiers for submission (e.g. Marketing Authorization Applications, Variations, Renewals, etc.) to regulatory health authorities, including, but not limited to:


coordination and follow-up on authoring activities and action items logistics related to document check-in initiation and coordination of authoring workflows support in finalizing authoring of CMC documentation by ensuring adequate formatting in line with the current style guide, where applicable

Health authority queries:

Support response preparation for health authority queries, including, but not limited to:


timeline management and coordination of response authoring response review comment consolidation, query reviewer follow-up and coordination of any other follow-up activity

Lifecycle management:

Support CMC regulatory lifecycle management activities for commercial products, including:


coordination and updating country-specific documentation aligned to global core documentation preparation of CTD Module1 documentation conducting consistency and QC checks on submission packages

GMP Management Team:

Support global GMP clearance activities as a member of project's GMP teams, act as point of contact for global RACMC colleagues, external partners and affiliates to enable GMP clearance of respective sites on-time according to project plan. Coordinate on-time document procurement and keep track of all required activities

Database Support:

Operative support of EU RACMC across project teams in maintenance of database entries for multiple regulatory purposes, e.g. Veeva HAQ, Master ToC, JIRA, GRATIS, eQMS, etc Archive or support archiving of regulatory and other files.




Personal Skills and Professional Experience:


Technical assistant (PTA, MTA, CTA, BTA, lab assistant), nurse or equivalent or bachelor degree. Several years working experience in pharmaceutical industry, preferred in regulatory affairs, CMC development or in a Clinical Research Organization. Team oriented and forward-thinking attitude. strong interpersonal and communication skills. structured and independent way to working. talent for organization. computer proficiency (e. g. MS office, document management systems, databases). strong written and verbal communication skills in English and German, third language preferred. Apply now