Senior Regulatory Compliance Specialist
2 days ago
Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team.With 3+ years of experience in handling new registrations, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.Strong communication and collaboration skills, ability to work independently.Key Responsibilities:Handling new registrations, life cycle management, and renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets.Preparing and delivering regulatory submissions from a global and regional perspective.Reviewing Marketing Authorization Applications & Variations for filing in various regions.Required Skills:3+ years of experience in regulatory affairs.Knowledge of regulatory frameworks and guidelines.Strong communication and collaboration skills.Ability to work independently.Benefits:This is a fantastic opportunity to work with a leading pharmaceutical company and contribute to the development of innovative products.We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.
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Coimbatore, Tamil Nadu, India Cornerstohn Solutions Full timeCompany DescriptionCornerstohn Solutions is dedicated to providing intelligent solutions designed to meet diverse requirements and deliver comprehensive outcomes. With a commitment to excellence, we empower clients through customized and innovative approaches to achieve their goals. For more information or inquiries, please reach out at Role DescriptionThis...