Stefan Wagner Email & Phone Number

-Coordination of projects as part of compilation and updating of CMC documentation for the assigned Dr. Falk Pharma medicinal products->Life Cycle Management for the quality part of the product dossiers in cooperation with QA, QC, SCM o Preparation and evaluation of relevant CC procedures and their regulatory implementation (variation management) o Point of contact for health authority inquiries->Responsible person for RA tasks in crossdepartmental projects (e.g. CMO product transfer, product formulation change projects)-Development of regulatory strategies and coordination of RA procedures for new registrations as well as maintenance of existing registrations in the APAC region (country responsibility for China, Vietnam, Singapore)-Further development of procedures in collaboration with other departments->Establishment of a cross-country and cross-product process for regulatory implementation requirements

-Representation of Regulatory Affairs in teams to develop new applications and further product development for non-pharmaceutical products (food supplements, cosmetics, medicinal devices)-Preparation, review and maintenance of regulatory documents according to current standards-Execution of regulatory procedures within mandatory deadlines-Point of contact and key partner for relevant technical departments and experts (CMC, R&D, Project Development, Supply Chain, Manufacturing) as well as for counterparts and health authorities-Point of contact for Medico- and Nutrivigilance

-Preparation, review and maintenance of regulatory documents and related dossiers according to current standards-Execution of regulatory procedures for post-approval procedures and special health authority requests within mandatory deadlines-New License Applications in existing and new markets-Point of contact and key partner for relevant technical departments and experts (CMC, Supply Chain, Manufacturing) as well as for counterparts and health authorities-Acting as interface with Label Management and CMC for process development-Point of contact for Pharmacovigilance-Participating in inter-departmental projects to achieve process optimization-Supervision of pharmacy students-Representation of Regulatory Affairs in teams to develop new applications and further product development for pharmaceutical products

Waltenhofen, Bayern, Deutschland

-Pharmaceutical advice to patients-Plausibility Checks-Hazardous Substances Officer

Berlin, Deutschland

-'Pharmacist in Training' 6 months-Pharmaceutical advice and formulation preparation

-'Pharmacist in Training' 6 months-Solution strategies for more efficient processing of change control backlogs in Regulatory Compliance Department

3Rd State Examination (Equivalent: Certified Pharmacist)

2Nd State Examination (Equivalent: M.Sc. Pharmaceutical Sciences), Pharmaceutical Science/Pharmacy