Drug Regulatory Afffairs Consultant - CMC

• Postgraduate in Pharmaceutical Sciences (Pharmaceutics) having gained extensive conceptual knowledge and research exposure in the discipline of Pharmacy. Comprehensive exposure in problem solving activities in the pharmaceutical sciences.

• Pharmazie

Fresh Filing: Preparing high quality initial marketing authorisation application (MAA) dossiers (eCTD formats) of drug product for generic filings, in EU (European Union) within the specified time schedule.

Single-handedly running Decentralised Procedure (DCP) and National Procedures with positive outcomes including national phases of DCP (United Kingdom, The Netherlands, Sweden, Germany, Poland, Italy, Malta etc.).

Prompt and adequate response to query on submitted registration dossiers during Phase I and Phase II of DCP procedure(s) or during National procedures to ensure timely product approval.

Writing & compilation of Module 1, Module 2 (2.2, 2.3 QOS), Module 3(3.2.S and 3.2.P-CMC documents), Module 4 and Module 5 for eCTD dossier publishing.

Supervision of pre-submission product development activities, selection of reference product for development, review of product development reports, Bioequivalence study protocols, preparation of SmPC, PL, label and mock-ups for submission including liasioning and coordination with different stakeholders.

Preparation & submission of Pre-IND packages for New Drug Application (NDAs) for USFDA.

Life Cycle management & Product Continuity: Preparation & submission of Renewal dossiers/variations Type IA, Type IB (minor) & Type II (major)/ article 61.3 notification packages for submission, prompt and adequate response to query to ensure product continuity.

Compliance: To prepare approval packages (license particulars) for ensuring the compliance for supplies at manufacturing location. To ensure archival of submissions (Registration/Re-registration dossiers/variations/notifications/RTQs) in organisation repository system. Ensuring compliance of supplies for EU batch release.

Ensuring the compliance of current supplies to EU with currently implemented Falsified Medicines Directive (FMD) regulation. Registration of Marketing Authorisation Holders (MAHs) at European Medicines Verification Organisation (EMVO) portal and EU country level National Medicines Verification Organisations (NMVOs) and handling of EMVO portal. Preparing master data for product portfolio as required by FMD regulation. Liasioning with Contract manufacturing Organisations and serialisation solution service providers.

Pharmaceutical and Regulatory IT competence includes handling of tracelink, eCTD publishing tools, EU CESP submission portal, Eudralinks, MHRA Intralinks portal, DCM, trackwise etc.

Review of DMF’s, product development reports, API/excipient/packaging certifications, manufacturing records, stability protocol data, hold time study protocol & reports, in-use stability protocol and report dissolution/impurity profile data, BE results, process validation and analytical method validation, reference and working standards data and their adequacy for filing.

Master of Pharmacy with specialisation in Pharmaceutics and over 6 year experience in regulatory affairs