Novartis
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.
Job Title:Â Â Â Regulatory Specialist-I
Job Description/Nature of Work:   1.Coordinate timely and provides specific support to activities in relation to high quality preparation of all necessary supporting documentation by internal or external parties for submission in Most of world, LACan including Canada, Region Europe (non EU countries) and Greater China. 2.Independent procurement of various regulatory documents needed to achieve and maintain marketing Authorizations in collaboration with other line functions (eg: Ordering Certificates, CFG, GMP, Registration Samples, COA’s and other regulatory documents as per the need). 3.Ensuring timely dispatches to countries with traceability and transparency of all the transactions. 4.Manage the interaction with RA colleagues in CPOs for regulatory maintenance activities and timely submissions. 5.Implement prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned activities. 6.Conducting surveys for all assigned projects and maintenance of up to date country requirements list across all the regions. 7.Work within the support systems and processes to enable accurate documentation and data. 8.Ensure key processes/systems are in place and functioning efficiently
to facilitate timely submissions. 9.Collaborate with relevant GLFs in creating and implementing strategies and action plans to ensure the maintenance of product licenses for as-signed Global portfolio brands for assigned countries. 10.Independent procuring of various regulatory documents needed to achieve submissions in collaboration with other functions within Novartis and outside such as a) TRD, Reg CMC, Global labeling etc for renewals b) SCM, Allpack for samples c) HAs such as Swissmedic/ Consular Services for certificates 11. Provide operational support in creation of regulatory strategies and plans for New registrations/ Production Transfers/Renewals to ensure CPPs, GMPs and Samples are available in time for the assigned global portfolio brands world-wide in line with regulatory commitments. 12. Managing & providing the support/guidance in term of ensuring that all activities are performed according to business rules and guidelines by Vendor Associate. Ensure yearly objectives/development plan and review performances for Vendor Associate as assigned by BOE Head.Qualifications:Â Â Graduate or Post Graduate in Pharmacy (e.g.Biotechnology, Pharmacology, Quality] or equivalent Excellent English required (oral and written). About 5-6 years in the relevant field Graduate or Post Graduate in Pharmacy (e.g.Biotechnology, Pharmacology, Quality] or equivalent Excellent English required (oral and written). About 5-6 years in the relevant field
