Independent planning and implementation of change notifications, renewals and new authorizations
Knowledge of CP, MRP, DCP as well as national procedures
Creation of product-relevant texts such as technical information, instructions for use and training materials. In addition, extensive experience with labelling and regulatory text adaptations following originator changes
Experienced in cross departmental collaboration, whether with CMC, Labeling, PV, or international affiliates, and possesses in depth knowledge of global regulatory requirements and landscapes
Has already worked with K-Recruiting several times. The feedback has always been excellent
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Studied Biology at the University of Cologne, Germany
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Regulatory Affairs Manager, eCTD Submissions & Updates, Amendments, Renewals, LCM, Compliance, Labelling Adaption, Liaison with Authorities (e.g. BfArM), Centralised Process, Pharma, Biotech, Combination Products
Key-Facts
Extract from Previous Activities
Own Company
Senior Regulatory Affairs Consultant
Pharmaceutical Company (via K-Recruiting)
Regulatory Affairs Manager
Submission management
Labelling: Adjustment of German product information texts (M 131)
Rare diseases (bile therapy and antineoplastic agents) (Rx)
Hard capsules
Database maintenance/document management
Complex change notifications (CMC + Safety), worksharing, extensions, PAM, PASS protocol and PSUR submissions
Change control management
Updating CTD Modules 1, 2, and 3 documentations
Application for CPPs and other administrative documents
Budgeting and initiation of payments
Interface function
Pharmaceutical Company
Regulatory Affairs Manager
Generics (22 different APIs (small molecules) and their finished products) (Rx)
Generic new approvals + maintenance of existing national approvals
Transfer of drug approvals to a new marketing authorization holder
Preparation for product launches (launch relevant change notifications)
Labelling: Creation and adjustment of German product information texts (M 131)
Labelling: Creation of German decision templates
Labelling: Originator text updates
Administrative, CMC, and safety change notifications
Submission management
Change control management
Database maintenance
Budgeting and initiation of payments
Pharmaceutical Company
Regulatory Affairs Manager
Corticosteroids, anti-acne preparations, antiviral agents (Rx)
Veregen, Skinatan, Beloren
Cream, ointment, emulsion, solution
Creation of regulatory expert reports for business development/diligence process
Dossier audit
Biopharmaceutical Company
Regulatory Affairs Manager
Rare diseases: Immunologics, Hematologics, large molecules: Immunoglobulins (Rx)
Human Albumin (IgG), Privigen, Rhophylac, Berinert, Hizentra
Injection solution/infusion solution
Document management (Documentum database)
Submission management and tracking of regulatory activities such as change notifications, extensions, responses, PSUR/PBRER, CCDS/CCSI updates, etc.
Creation/update of CTD Module 1 documentation
Interface function
Pharmaceutical Company (via K-Recruiting)
Regulatory Affairs Manager
Non-ionic radiographic contrast agents (Rx)
Artirem, Dotarem, Lipiodol, Optiray, Patentblau, Xenetix
Injection solution/infusion solution
Medical/Drug Safety Information Management
PV signal management/signal detection and analysis
Evaluation of adverse effects and safety signals + follow-up process
PV database maintenance and data entry in ARISg
Retrieval of adverse event cases from EudraVigilance
MedDRA coding of adverse effects
Literature screening/monitoring of scientific journals
Monthly reconciliation of adverse event cases