Job Description

Summary Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.

Key Responsibilities

• Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions. Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g., FDA or EMA). Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans.
• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
• Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

• Functional Breadth.

• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Skills Desired Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance