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 : Lead Regulatory Affairs GDD India
Job Description
• 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.
Major Accountabilities
• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large 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.
• Contributes to and often leads the development of departmental goals and objectives.
• Regulatory related
• Provide inputs to RA team in regulatory strategy for pipeline products
• Facilitate timely submission/approvals of NDAs, FDCs, add. ind./LE, import regn/ renewals, CTAs, & Reg compliance and f-u for query responses
• Track regulatory committees meetings viz. SEC, Tech comm, IND, DTAB etc
• Develop and build rapport with CDSCO officials
• Facilitate Sr RA and Medical team members for meeting with the HA officials
• Act as a Single Point of Contact (SPoC) for Novartis at CDSCO
• Support RA team for SUGAM Portal and query resolution
• SMART Regulatory intelligence for competitors approvals
• Abreast with constantly evolving regulatory environment, newer guidelines,
• Establish relationships and manage regulatory work with other key Regulatory Authorities
• Timely submission of Pharmacovigilance/ patient safety teams Pricing and policy related -Facilitate timely submission/ approvals of price proposals and act as SPoC for all NPPA queries resolution, ensure needed follow-up and facilitate closure -Track all pricing authority meetings for timely inclusion of our proposals and facilitate meetings of our team -Support Head, Country Public Affairs, in participating in industry meetings with authorities for pricing decisions/ proposal, sharing NVS/ OPPI/ trade associations thought process. -Solving any open issues with respect to IPDMS database compliance --Establish and strengthen rapport with NPPA, DoP officials
Candidate Profile
(Minimum) Must have - Bachelor’s degree in any specialization.
(Desirable) – Bachelor’s in Pharma/ Science, Master’s
• Operations Management and Execution Project Management Representing the organization Functional Breadth Cross Cultural Experience English NA
• Critical Negotiations Relationship Management Working experience within the pharmaceutical industry Well-developed record of successful relationship management Indian (Other) Regulatory Strategy Regulations & Guidelines Health Authorities preferably A post-graduate or graduate in pharmacy, science, health discipline or life sciences (minimum) with minimum 15 years experience
Additional Information
Experience : 5+ years
Qualification : Bachelor’s in Pharma/ Science, Master’s
Location : Delhi
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 30th July, 2021
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