Openings in Novartis for Sr. Manager in Global regulatory affairs

Openings in Novartis for Sr. Manager in Global regulatory affairs

 

Novartis Logo


About Novartis : 

One of the largest pharmaceutical company of swiss origin located in Basel, Switzerland. Originated by merging of Ceiba and Geigy in 1996.The company further classified its operations to 3 major divisions: Sandoz (generics), Alcon (eyecare) and innovative medicines, it has 33.3% ,24.9%  of the Roche shares  and identic pharma respectively. The firm established its Multi functional center in Hyderabad, which covers of around 870,000 Square feet.
The pharma giant has a large portfolio of medicines in treating areas including but not limited to osteoporosis, Psoriasis, COPD, Hypertension, Alzheimer’s disease, heart failure, malaria, Amoebiasis, Asthma, schizophrenia and so on. This laid its step in animal health division, pests and rodent control by providing many varieties of products like milbemax, interceptor, Acara.
United states department of Health and human services in the year 2009, awarded Novartis with $ 486 contract for producing cell based influenza vaccine with a motto of 150,000,000 doses of flu pandemic vaccines with in 6 months. When gone through the financial aspect, it has a revenue of $ 53 billion and market capitalization of over $ 209 billion.
Recently decoding the hand of Artificial intelligence around pathological cancer, by recognizing the cancer at various stages. The firm has huge corporate responsibility helping in addressing the needs of undeserved populations, 24 Million patients reached access through the programs in 2018 and over 17 Million people reached training, health education services.

About the Job : 

Experience : Minimum 10+ years of regulatory experience 

Roles & Responsibilities : 

Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• 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.
Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Build strong network externally, with state FDA, CDSCO offices and participation in industry meetings as needed.
• 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.
• 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).
• 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).
• Review of global dossier summary documents.
• Contributes to and often leads the development of departmental goals and objectives.
• For assigned TAs, develop regulatory strategy for pipeline products and ensure flawless execution of strategy.
• F-u with Head Public Affairs to monitor progress of review/ approval
• Oversee all regulatory compliance related to assigned TAs.
• Ensure collaborative working relationship with internal cross functional stakeholders
• Stakeholder Engagement, Operations Management and Execution Project Management Representing the organization Functional Breadth Cross Cultural Experience.
• Review and approval of promotional material
• Leadership initiatives, Simplification of procedures, coaching of RA ex/ Sr ex, Co-ordinate for impactful SEC meetings, Timely responses to HA queries, Keep abreast of newer reg guidelines and impact assessment
• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in HA interactions to achieve business objectives.
• People Management responsibility including development and coaching of direct reports.
• Adherence to Novartis policy and guidelines -Project & stakeholder feedback
• Reviews and submits Risk Management Plans.