Regulatory Compliance Specialist

Quality Assurance Executive Job Description"> We are seeking a highly skilled Quality Assurance / Regulatory Affairs professional to join our esteemed organization in the Medical Device Industry.Key Responsibilities:Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.Coordinate with regulatory bodies to obtain required permissions and...

Senior Manager/Chief Manager-Compliance Job OpeningOur organization is seeking an experienced and skilled Senior Manager/Chief Manager-Compliance to join our team.This role will involve leading the firm's compliance efforts, ensuring that all regulatory requirements are met, and maintaining a strong relationship with clients.Coordinating with clients for...

We are seeking an experienced professional to lead our CMC regulatory activities for USFDA submissions.Key Responsibilities:CMC Regulatory Activities: Lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.Annual Reports: Oversee compilation and submission of Annual Reports, amendments, and deficiency...

**Job Description:**We are seeking a highly skilled and detail-oriented specialist to join our team. The candidate will play a key role in managing statutory and tax compliances, audit coordination, and monthly financial closing.---**Key Responsibilities:1. Compliance & Taxation• Ensure timely and accurate compliance with all statutory requirements,...

Job Title: Business Compliance SpecialistWe are seeking a dedicated expert to guide companies through business registrations, state tax registrations, and maintain ongoing statutory compliance in India.This role demands meticulous attention to detail, comprehensive understanding of Indian corporate laws, local and state regulatory frameworks, and excellent...

Job Title: Business Compliance SpecialistOverview:We are seeking a highly organized and analytical individual to join our team as a Business Compliance Specialist. This role is ideal for someone with experience in managing US federal, state, and local compliance and business registrations.Key Responsibilities:Assist clients with business entity formations,...

Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Associate to support end-to-end submissions for global markets.Lifecycle Management Expertise:Compile and review CTD dossier modules for Lifecycle Management (LCM) activities.Prepare Variation documents and/or evaluate post-approval changes in compliance with global regulatory...

Quality Assurance Compliance SpecialistThe Quality Assurance Compliance Specialist will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in the production of sterile injectables.Responsibilities:Document Control: Prepare and review QMS-related documents, including SOPs, work instructions,...

Job Title: Regulatory Affairs ProfessionalWe are seeking a highly experienced regulatory professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring adherence to applicable regulations.We need someone with a...

QA-Compliance – Sterile InjectablesExperience Required: 10-15 yearsLocation: RemoteDepartment: Quality AssuranceNo. of vacancy: 01Key Responsibility: Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.Review, approve, and trend Change Control (CC) records,...