Regulatory Specialist

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...

Regulatory Affairs ExpertiseThe role encompasses a wide range of responsibilities, including the preparation and submission of regulatory dossiers to global health authorities.The specialist will be responsible for authoring, compiling, and submitting regulatory dossiers in various formats, including eCTD, ACTD, and CTD.Gap analysis will be conducted to...

Job OverviewThe Entity Compliance Specialist plays a pivotal role in ensuring the organization's entities comply with relevant laws and regulations.Key ResponsibilitiesEnsure all organizational entities adhere to applicable laws and regulations.Provide expert advice on compliance matters to stakeholders.Conduct regular audits and reviews to identify and...

Job Description:We are seeking a seasoned professional to assume the role of Senior Regulatory Affairs Associate. As part of our dynamic team, you will be responsible for handling various tasks related to new registrations, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small...

Information Specialist IIIThe role of an Information Specialist III involves preparing regulatory-compliant documents for international customers.This requires searching various reference sources and supplier SDS for required information, reconciling discrepancies, and performing evaluations according to toxicological, environmental, chemical, and physical...

Senior Compliance SpecialistThis position is responsible for ensuring adherence to corporate policies and international regulations.Maintain compliance with regulatory requirements and company policies.Develop and implement quality management systems to improve organizational efficiency.Plan and execute audits to ensure regulatory readiness.Collaborate with...

Role: Labeling Data Remediation Specialist Experience: 4–8 years Key Responsibilities - Review, validate, and correct product labeling data across systems. - Identify gaps, inconsistencies, or missing data in existing labeling records. - Remediate labeling fields to match regulatory standards and local market requirements. - Ensure alignment between...

Key Responsibilities for NDA Contract Specialist role include reviewing non-disclosure agreements validating order documents and overseeing contract processes. The specialist will demonstrate attention to detail independent judgment and ability to work with minimal supervision in a fast-paced environment.ResponsibilitiesReviewing complex legal agreements and...

Medical Safety Specialist OpportunityThis role involves conducting thorough reviews and assessments of case safety reports from clinical trials, spontaneous, and solicited reports. You will determine regulatory reportability of cases within assigned therapeutic teams and across all products/sites in a timely manner.Your responsibilities will include:Triage...

Compliance Coordinator RoleThis is a pivotal position that demands a high level of professionalism and organizational expertise.We are seeking an experienced professional to provide critical support services to our team and stakeholders.The ideal candidate will have exceptional legal and administrative skills, enabling them to effectively manage documents...