Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

257137/2

IHRE AUFGABEN:

-Leading the joint efforts for the development of product approval strategies in a timely and accurate manner
-Managing dossier preparation for product approval in collaboration with product and project management
-Assisting in the preparation and maintenance of company/product documentation compliant to law
-Being responsible for global (e.g. JECFA) or regional (e.g. CRN; ERNA; APIC) representation, networking and shaping activities
-Providing input on changing regulatory environments
-Support TQM for product specific aspects in customer Quality agreements
-Managing issues related to product quality aspects, e.g. impurity CCR in close cooperation with all internal functions (e.g. QA, Marketing & Sales, DSCM, PM)
-Representing the client in external working groups as participant and in contact with officials from authorities and auditing units

IHRE QUALIFIKATIONEN:

-University degree in natural sciences and/or life sciences
-In-depth experience in the field of pharma regulatory affairs/quality
-Interdisciplinary knowledge in the areas of analytics, chemistry and production process, biology and toxicology (solid basics)
-Knowledge on regulations and standards for DNP and DFS business
-Fluent in English, every additional language beneficial
-Strong communication skills and good team working skills

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager