Regulatory CMC Manager (m/f)

REFERENZNUMMER:

352647/11

IHRE AUFGABEN:

-Act as single point of contact and advisor for worldwide regulatory intelligence information on the site
-Maintain a close collaboration with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
-Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising issues for resolution
-Coach, train and develop the site’s personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information
-Support the site in generation of effective change control strategies
-Support the CMC documentation preparation by facilitating timely provision of good quality source documentation
-Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority requests for site specific products

IHRE QUALIFIKATIONEN:

-Strong experience in production and Regulatory Affairs CMC field
-University degree in relevant field
-Fluent writing and speaking skills in German and English

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager