Executive RA GDD

Job Description

200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.Your Responsibilities:Your responsibilities include but not are limited to: Ensures a controlled documentation system, record retention, and information servicesincluding electronic records retention processes in accordance with regulatoryrequirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly ofregulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customersMajor Accountabilities Manages medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Contribute to strategic and technical input /support to drive implementation of globalsystems, tools and processes to support global development projects and/or marketedproducts. Write, edit and /or manage the production of high quality clinical documentation (e.g.Clinical Study Reports & Summary Documents) for submission to regulatory authorities in support of marketing applications. Developing professional expertise, applies company policies & procedures to resolve avariety of issues. . Frequent internal company and external contacts. Represents organization on specificProjects.Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Refers to established policies & procedures for guidance.Contributes to some cost center goals & objectivesEEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements What You ll bring to the role: 2+ years of relevant experience in Data Science.Collaborating across boundaries.Adherence to Novartis policy and guidelines.Project & stakeholder feedback Assist Head RA, GDD /Manager for regulatory intelligence; as appropriate.Compilationand HA submissions of New Drug applications, Line extensions, additional indications alongwith the site registrations, renewals and production transfer applications for NovartisPharma products. Compilation and HA submission of Clinical Trial Application (CTA)dossiers for GDO projects as per defined timelines along with their compliance activitiesNovartis India Public Affairs for monitoring progress to take next actions steps asappropriate in consultation with RA, GDD Manager/ Head. Maintenance of compliance activities like PSUR, Post approval changes like CMCs of imported products and their HA submissions. Maintenance of on-going CT projects: Independently, ensure various regulatorycompliances related to the clinical trial projects from submission to study completion. Interact with local GDO group for finalization of texts related to clinical trialconsignment labels / licenses and ensuring that the same are implemented for timely andsmooth clearance of clinical trial materials. Review of protocol, investigator brochure,IMPD documents and entire clinical trial package and coordinate with local GDO group to ensure completeness for timely HA submission.,

Keyskills :
study reportspublic affairsline extensionsregulatory affairsmonitoring progressdevelopment projectsclinical documentationsummarizing informationregulatory intelligencepoliciesprocedures