A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Regulatory Associate-II
Job Description
1. Develops operational excellence in all activities relating to maintenance of DRA business for marketed product portfolio in AMAC/LACan, including but not restricted to licence renewals, site transfers, and other critical activities 2. Ensures excellence in planning & productivity for timely delivery of critical regulatory materials including renewals, registration samples & certificates for AMAC/LACan and other regions (as per requirements).
3. Co-ordination with Global Translation Services for translation of required regulatory documents especially for LATAM countries. Provides operational support for DRA AMAC/LACan regulatory compliance activities.
4. Delivers operational support to regulatory activities related to new product planning, for the AMAC/LACan region.
5. 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, All pack for samples c) HAs such as Swiss medic/ Consular Services for certificates
6. Maintenance of up-to-date country requirement list and renewal plan by conducting need-based surveys
7.Co-ordinate for GMP,TSE and MA documents with the relevant sites and negotiate the delivery of approved technical source documents in accordance with submission timelines.
8. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines.
Candidate Profile
Graduate or Post Graduate in Pharmacy 3-5 Yrs English Responsible for delivery of critical regulatory elements impacting marketed and new products (across Gen Med & Onco) covering approx. 100 countries in AMAC/LACan and other Regions
Experience: 3-5 Yrs
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Research & Development
Job ID: 224925BR
Last Date: 21st November, 2017
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