Job ID: 362456BR
Business Unit: Sandoz Global Development
Work Location: Mumbai, India
Company/Legal: EntitySdz Pvt Ind
Functional Area: Research & Development
Job Type: Full Time
1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Your responsibilities include but not are limited to:
- 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.
- Managing projects end to end to define regulatory strategy for the regulatory submissions where required. Identify content, quality and/or timelines issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Identify the required documentation for regulatory submissions and negotiate the delivery of approved source documents in accordance with project timelines.
- Author high-quality CMC documentation (dossiers) as per Regulatory guidelines, applying CMC regulatory strategies (wherever needed), assuring technical consistency and regulatory compliance, meeting defined timelines and e-CTD requirements.
- Developing professional expertise, applies company policies & procedures to resolve a variety of issues. Frequent internal company and external contacts. Represents organization on specific projects. 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.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with stakeholders, partners, and customers.
- University or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written).
- At a minimum 4 years experience in the Pharmaceutical area, specifically in Regulatory CMC
- Experience in the Regulatory CMC, area is preferred, Module 3 submissions
- Organizational awareness and experience working cross-functionally and in global teams is a plus
- Ability to work under pressure, demonstrating initiative and flexibility
- High level understanding of Regulatory quality, standards and policies.
- Attention to detail and quality focused