Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

252827/1

IHRE AUFGABEN:

-Perform regulatory Due Diligence for defined product dossiers and establish gap analysis against country submission content plan for countries in scope
-Develop and implement appropriate regulatory strategies to ensure successful products submission & approval
-Act as counterpart towards regulatory contact from the external partner and ensure productive and efficient interactions
-Define regulatory work package for defined products and coordinate planning of submissions
-Manage applications for new marketing authorization, answer to questions & any other local request, variations and renewals
-Adapt dossiers according to company standards and country specific requirements
-Coordinate the provision of supporting documents with external partner, with regulatory functions and other departments in case of content related issues
-Review regulatory dossiers and documents (protocols, reports and other types of regulatory documentation) liaising with other regulatory functions as appropriate
-Maintain direct contact with local country RAs and external partner and monitor the submission process
-Provide customer and business oriented solutions for problems during submissions
-Ensure understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly

IHRE QUALIFIKATIONEN:

-Degree in a Life Science or related discipline
-Experience with LCM activities in at least two regions (e.g. Europe, LATAM, APAC)
-Experience in pharmaceutical industry
-Prior experience in performing regulatory due diligence
-English skills (business fluent)
-German skills (business fluent)

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager