Job Description

Company Description Welcome to the official LinkedIn page of Aishwarya Group, an Indian pharmaceutical organization specializing in various dosage forms, geographies and therapy areas across the globe to provide healthy quality of life to patients. Aishwarya Group\'s operations are centered around quality, relevancy, and value addition. With over 35 production lines and specialized facilities that are dedicated to research, innovation, and manufacturing, the company has increasingly evolved into a global healthcare partner. Role Description This is a full-time on-site role in Mumbai for a Head of Regulatory Affairs. The Head of Regulatory Affairs will be responsible for ensuring regulatory compliance, regulatory strategy, regulatory submissions, and excellent regulatory affairs practices within the company. The Head of Regulatory Affairs will lead a team in this effort and report to the CEO and Managing Director of the organization. Qualifications Strong knowledge of regulatory compliance, requirements, and strategy in the Pharmaceutical field. Experience in regulatory affairs and the triggering/submission process across Europe, US (NDA/ANDA/Para 5), SAHPRA, ANVISA, ENVIMA and Ability to communicate coordinate various QP audits, and respond to regulatory queries. Leading the International Business Project Management Office. Proven experience in developing and implementing regulatory strategies in pharmaceutical organizations Ability to lead and mentor a team of regulatory affairs professionals to ensure compliance and timely submissions Excellent organizational and communication skills with the ability to work collaboratively with internal teams and external partners A Master\'s degree in a relevant scientific discipline, such as pharmacy, chemistry, or biology At least 12 years of experience in regulatory affairs and compliance within the pharmaceutical industry Experience in dealing with regulatory agencies worldwide An ability to analyze scientific data and regulatory information and provide strategic advice and direction to the organization

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