Regulatory Co Ordinator(Evening Shift)

Company Overview: Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle. Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines & real-time solutions. Our clinical trial support services & consultations are tailored to foster your product and requirements. We aim to deliver high-quality data and solutions to make your clinical trials a success.

We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. Job Purpose: The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies. Key Responsibilities:

Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activitiesDevelop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelinesManage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certificationsCoordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findingsKeep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely mannerBuild and maintain positive relationships with regulatory authorities and other external stakeholdersProvide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assuranceCollaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectivesEnsure timely and accurate reporting of regulatory activities and metricsQualifications:

Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy01 years of experience in regulatory affairs, fresh graduates will also be preferredIn-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated productsExcellent communication, interpersonal, and problem-solving skillsAbility to work independently and manage multiple projects simultaneouslyStrong attention to detail and accuracyExperience working in a fast-paced, deadline-driven environmentEmployment Type: Full-Time, On-siteShift: EveningTimings: 6 PM to 2 AMCandidates with relevant background will be preferred. Powered by JazzHRsIjixipAGl