Shelly Koshaal

Senior Manager Regulatory Affairs & Pharmacovigilance @Organon

IN

Strategic Leadership: Provide strategic direction to ensure regulatory compliance across all aspects of the business. Participate in senior management discussions and decision-making processes related to product development, regulatory submissions, and market access.• Regulatory Strategy Development: Develop regulatory strategies that align with business goals. Assess regulatory requirements for new product development, lifecycle management of existing products, and market expansion strategies. Develop, update and implement local regulatory procedures promptly, in close synergy with stakeholders.• Regulatory Submissions and Compliance: Lead timely and accurate preparation, submission, and maintenance of regulatory filings to regulatory agencies such as CDSCO, DRAP and others.o Ensure the preparation and submission of electronic and paper regulatory submissions for registrations, renewal variations, an change notifications etc. according to applicable regulatory requirements, guidelines and business plans.o Ensure adequate follow-up with regulatory agencies and quickly address agencies\' queries for regulatory information.o Ensure timely submission and follow-up of both labeling and quality-related variations to the marketing approvals, incooperation with the key stakeholders.o Efficient regulatory input for packaging and label components to ensure timely implementation of Label/ artwork efforts.o Plan & track all regulatory actions o Periodic archival and review of regulatory management tools. • Cross-functional Collaboration: Work closely with other departments such as Sales & Marketing, R&D, clinical development, quality assurance, and legal to ensure regulatory considerations.• Regulatory Intelligence: Monitor regulatory trends, changes in regulations, guidelines, and competitive intelligence.• Audit Readiness and Inspections: Support local PV audits and inspections including readiness activities and support other audits/inspections.

Punjabi University

M.B.A

Guru Nanak Dev University

B. Pharmacy