M K

Mufassil Khan

40 ans • London

Résumé

• A self-motivated committed team player, motivating and participating effectively with others; bringing planning, organisation and co-ordination skills to group work whilst leading and completing projects independently.

Expériences

Regulatory CMC Asscoaite

Services à la personne

• Working on a Compliance Approved Module 3 (CMC) Project for Amgen on behalf of GENPACT Pharma link. • Determining discrepancies between the registered information in the Core Module 3 CTD sections for Drug Substances and Drug Products against the Manufacturing Site data in the EU and International regions for Biologic Products. • Accountable for post approval life cycle management process development. • Redactions, Authoring of Approved M3 CMC sections. • Managing the various stages of a project lifecycle: initiation, monitoring, management, escalation, closing • Liaising with manufacturing site to obtain supporting documents as needed. • Ensure that submission packages are reviewed against current local guidelines. • Maintaining systems and databases as per internal SOPs and policies. • Assist in the development of global regulatory strategy and update strategy based upon regulatory changes • To create/update current approved Module 3 for client markets • Establish and maintain sound working relationships with partners and customers • Performs other tasks or assignments, as delegated by Regulatory management.

Regulatory Operations Associate

Services à la personne

• To assemble, prepare and submit variations, RFI’s, RTQ’s amendments, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and ICH guidelines. • To read, understand and submit compliant dossiers (paper and electronic format) to regulatory authorities. • To manage in-coming queries on procedures currently underway e.g. building dossier structure • To request documentation from internal and external bodies to support registration applications and maintenance of product licenses. • To co-ordinate translations with and from external translation vendors. • To publish and submitting different packages (Nationals, MRPs DCPs, CP) via Nees, e-CTD format to portal via CESP and EMA gateway. • To act as a reviewer and perform QC check for all the submissions before to be submitted to the health agency • Regulatory data submission including Modules 1 to 5 • Building table of contents (ToC) using Nanokinetic tool and validating submissions using EURS/LORENZ validator. • To gain a working knowledge of document management systems after submission has made successfully by updating local databases and archiving them.

Quality Operations Executive

Services à la personne

• To monitor local product quality and compliance environment. • To check and review module 3 CMC information for compliance of the product. • To coordinate with regulatory team for CMC information for complain handling. • To resolve any module 3 CMC related issue with the quality complain of the Pfizer products. • To manage local in-take, triage, generation of complainant response for product quality complaint. • Log Pfizer Product Quality Complaint (PQC) under Pfizer complaint global database. • To participate in AQO promotional activities to engage and educate key stakeholders. • Developed good working relationships and communicate effectively with colleagues and other internal and external stake holders.

Formations

Edinburgh Napier University

2007 - 2008

Edinburgh, City of Edinburgh

Chimie / Biologie / Agronomie, Services à la personne, Conception / Génie civil / Génie industriel, Design / UX / UI,

Études / Statistiques / Data