Group Head-regulatory Affairs Information

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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address	Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website	www.novartis.in/
Holding	No Holding Details

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Group Head-regulatory Affairs

Provide leadership to the Regulatory Affairs Pharmaceutical team, act as a liaison for defining compliance requirements with FDA/CVM (Center for Veterinary Medicine) and lead regulatory strategy development to address pharmaceutical regulatory issues. Ensure professional planning and efficient registration of new products. Maintain the registrations of existing marketing authorizations in agreement with R&D, TechOps and Marketing directions and strategies. Plan and coordinate departmental budget strategies and activities by setting objectives, monitoring policies and practices, making expenditure recommendations, allocating resources and operating within set targets to control costs and ensure successful departmental operations. Be responsible for the management and development of staff by overseeing recruitment and training, evaluating performance, defining and assigning responsibilities, providing opportunities for career development, and improving departmental policies and procedures in accordance with company objectives. Plan, direct and coordinate North American pharmaceutical regulatory activities by establishing strategic and operational policies and goals, assigning responsibilities, managing team resources, coordinating customer needs and ensuring successful implementation, follow through and completion of tasks. Advise business and provide guidance/direction on regulatory compliance issues by maintaining knowledge of company performance, developing analysis, making recommendations and remaining current with related trends to provide the information necessary to establish future direction. Represent the company in regulatory-related trade associations and professional organizations. Communicate and interact with direct reports, department heads and Global Regulatory Affairs, by supporting and responding to priorities, resolving issues, applying government regulations or laws to facilitate financial, controlling, and operational issues and forecasts. Provide guidance/direction to the department managers in administering procedures and systems necessary to maintain proper records, and supporting adequate controls and services to perform timely, relevant and accurate company financial reporting. May contribute to special assigned activities and projects, or represent Regulatory Affairs in cross-functional assignments and projects. Desired Profile University degree in Life Sciences such as veterinary medicine, toxicology, pharmacy, chemistry or other comparable qualifications. . Minimum 5 years experience as government liaison or 10 years experience as a manager with an animal health company in the area of pharmaceutical development and Regulatory Affairs. In depth knowledge of the 21 Code of Federal Regulations, guidance documents and current trends in FDA policy. Knowledge and experience in developing pre- and post-CMC files. Knowledge and awareness of current industry issues and evolving trends in the regulated environment; both domestically and internationally. Advanced planning and tracking skills, capable of managing larger departments and multiple projects with respect to priorities and self-management. Proven track record of taking intelligent risks, courageous decision making and willingness to be held accountable for trade-offs and results. Excellent interpersonal, communication and information management skills. Demonstrated success in direct or matrix people management role, expert skill to facilitate/optimize contribution of team members as individuals and the team. Excellent ability to create visionary strategies and lead an organization through innovation. Experience 10 - 12 Years Industry Type Pharma / Biotech / Clinical Research Role Regulatory Affairs Manager