Regulatory Affairs Expert

2 weeks ago

udaipur, India beBeeCompliance Full time

Regulatory Affairs Specialist RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This individual will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory dossiers to global health authorities, and managing the lifecycle of products from authorization to market access.The ideal candidate will have strong analytical and problem-solving skills, with the ability to work effectively in a cross-functional environment. They will also possess excellent communication and collaboration skills, with the ability to interact with various stakeholders including healthcare professionals, regulatory agencies, and internal teams.Key responsibilities include:Preparing and submitting regulatory dossiers, including ANDA, NDA, BLA, MAA, and other lifecycle submissions.Conducting dossier gap analysis and converting and preparing dossiers in multiple formats.Managing responses to health authority queries through cross-functional collaboration and data collation.Required Skills and QualificationsTo be successful in this role, you will need:Strong knowledge of regulatory requirements and guidelines.Excellent analytical and problem-solving skills.Effective communication and collaboration skills.Ability to work in a fast-paced environment and prioritize tasks accordingly.BenefitsThis role offers a competitive salary and benefits package, as well as opportunities for professional growth and development. You will also have the chance to work with a talented team of professionals who are passionate about making a difference in the field of regulatory affairs.Other InformationPlease note that this is a full-time position, and the ideal candidate will be required to work in our office located in [location]. If you are interested in this opportunity, please submit your application, including your resume and a cover letter outlining your relevant experience and qualifications.

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