Regulatory Manager-I at Novartis


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 Manager-I

Job Description:
The DRA AMAC/LACan Business & Operations Excellence (BoE) associate /manager based in Hyderabad is responsible for delivering optimal Business & Operational DRA support for Asia, Middle East & African Countries (AMAC) and Latin America & Canada (LACan). The core responsibility for assigned activities is aimed at maximizing operational effectiveness of the DRA A/L organization (across Global/Regional/CPO in-terfaces) covering the whole portfolio lifecycle for (GenMed & Oncology) products. The BoE manager is expected to take a lead role in 1 or more assigned areas of responsibility with a mindet of ownership, quality; effectiveness of planning & resource allocation and to drive continuous improvement in daily operations.

1. Ensures excellence in planning & productivity for timely delivery of critical regulatory materials including regulatory components for product licence re-newals, registration samples & certificates for AMAC/LACan and other regions (as per requirements).
2. 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.
3. Delivers operational support to regulatory activities related to new product planning, for the AMAC/LACan region.
4. Provides overall guidance to Regulatory associates/consultants for day-day working.
5. Interfaces with various providers for 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 labelling etc for renewals
b) SCM, Allpack for samples
c) HAs such as Swissmedic/Consular Services for certificates

6. Maintenance of up-to-date country requirement lists and plans covering activities in scope through conducting need-based surveys & interaction with CPOs.
7. Takes leadership role in planning workload & anticipating and resolving business critical issues related to 1 or more assigned areas of responsibility.
8. Drives continuous improvement in areas of assigned responsibility.
9. Is able to contribute to assessment and implementation of additional activities & responsibilities in alignment with vision of enhanced role of Hyderabad BoE team with DRA AMAC/LACan.
10.Support Head BoE as and when needed in leading the drive for increased productivity and efficiency in interactions between Global LFs, BFs and DRA (global, region & CPOs) relating to regulatory submissions, approvals and maintenance of product registrations & ensure supply continuity for the entire pharma Gen-Med and Oncology portfolio for the AL region.

Candidate Profile
Graduate or Post Graduate in Pharmacy (e.g.Biotechnology, Pharmacology ,Quality) or equivalent Excellent English required (oral and written). About 6-8 years in the relevant field.

Additional Information:
Job ID: 184653BR
Location: Hyderabad
Experience: 6-8 Years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Research & Development
Business Unit: Global Develop NPH

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