Global Regulatory Expert

Regulatory Writing Professional">Authored regulatory documents, including Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents.Conducted formal reviews and approvals of authored documents following standard operating procedures.Managed regulatory writing activities for product submissions, including new and...

392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...

Job TitleRegulatory CMC Lead SpecialistThis role leads and implements all global CMC submission activities for assigned projects/products. It involves formulating and leading global CMC regulatory strategy, maximizing business benefit balanced with regulatory compliance.Responsibilities:Develop and implement global CMC regulatory strategies to ensure...

Key Responsibilities:Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia.Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documentation.Regulatory Compliance:Ensure compliance with global and local regulatory SOPs and...

Regulatory Compliance SpecialistA key role that demands expertise in regulatory affairs and the ability to manage global CMC submission activities with strategic oversight.Key Responsibilities:Develop, implement, and maintain global CMC regulatory strategies that align with business objectives while ensuring compliance with regulatory requirements.Oversee...

Job Overview"," A Regulatory Manager is responsible for implementing global regulatory strategy and managing operational activities in assigned regions. Key performance indicators include successful implementation of regulatory strategy, identification of main HA issues, successful participation in HA interactions, and adherence to company policy and...

Job Summary\We are seeking a skilled professional to join our team as an Associate Global Program Regulatory Manager. The ideal candidate will have experience in implementing regulatory strategies and managing operational activities.\Main Accountabilities:\\Develop and implement global regulatory strategies for timely submissions and approvals.\Partner with...

International Regulatory ProfessionalWe are seeking a highly skilled International Regulatory Professional to join our team. In this role, you will provide regulatory leadership and expertise for international countries, collaborating with various functions and local regulatory teams to optimize product development and regulatory approvals.Key...

Key Responsibilities:Develop and execute regulatory strategies to ensure timely submissions and approvals for assigned regions.Collaborate with regional teams to align on regulatory approaches and contribute to the development of departmental goals and objectives.Provide input into global regulatory strategy and participate in relevant regulatory boards to...

International Regulatory Lead Job DescriptionWe are seeking a highly skilled and experienced International Regulatory Lead to join our team. As an International Regulatory Lead, you will be responsible for advising global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and...