Global Regulatory Affairs Specialist

6 days ago

mangalore, India beBeeRegulatoryAffairs Full time

Job Opportunity OverviewWe are seeking an experienced professional to handle the registration, lifecycle management, and renewal of various biologicals, vaccines, recombinant protein molecules, monoclonal antibodies, plasma-derived products, and small molecules in global markets.Key ResponsibilitiesPursue new registrations, lifecycle management, and renewals for Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma-derived products, and small molecules across different regions.Contribute to regulatory submissions from a global and regional perspective by preparing and reviewing Marketing Authorization Applications & Variations for filing in key markets such as the US, EU, Japan, Canada, Switzerland, and Australia.Demonstrate expertise in the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.Develop strong communication and collaboration skills, with the ability to work independently, to ensure successful project outcomes.Required Skills and QualificationsTo succeed in this role, you will need:A minimum of 3 years of experience in Regulatory Affairs or a related field.Strong knowledge of the regulatory environment, including regional trends and requirements.Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.Ability to work independently and manage multiple projects simultaneously.BenefitsThis role offers a unique opportunity to grow your career in a dynamic and challenging environment. You will have the chance to:Contribute to high-profile regulatory submissions.Develop and maintain strong relationships with internal stakeholders and external partners.Stay up-to-date with the latest developments in the regulatory landscape.Additional InformationPlease note that this is a job description only and not a job posting. We are looking for talented professionals who share our passion for innovation and excellence. If you are interested in this opportunity, please submit your application for consideration.

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