Regulatory Affairs Expert

**Job Overview:**We are seeking a seasoned Regulatory Affairs expert with expertise in pharmaceutical and medical device regulatory compliance.The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Key...

Regulatory Affairs Specialist - CMCKey Responsibilities:Lead and manage submissions for USFDA compliance, ensuring timely preparation, review, and filing of regulatory documents.Oversee compilation and submission of reports, amendments, and deficiency responses to regulatory agencies.Collaborate with cross-functional teams to gather required documentation...

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...

We are seeking a highly skilled professional to join our client in the Medical Device Industry.Job Description:Quality Assurance and Regulatory AffairsEnsure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Coordinate with regulatory authorities for obtaining required permissions and approvals.Oversee risk management, clinical evaluation,...

Senior Medical Devices Engineer OpportunityWe are seeking a highly skilled Senior Medical Devices Engineer with extensive experience in quality management, regulatory affairs, and risk management to lead our medical devices team. This is an exciting opportunity for a professional to develop and implement quality management systems, ensuring compliance with...

Business Compliance SpecialistKey Responsibilities:Assist clients with business entity formations, including LLCs, corporations, partnerships and sole proprietorships.Manage federal business registrations, including obtaining Employer Identification Numbers (EIN), IRS filings, and compliance.Conduct state-specific registrations, including sales tax,...

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.Job OverviewThis role involves preparing Variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements. You will contribute to Lifecycle Management activities by helping to compile and review CTD dossier...

Job Title: Senior Business Analyst with HealthCareThe role of a Senior Business Analyst in the healthcare domain involves working closely with compliance and legal teams to ensure system changes, processes, and documentation remain compliant with healthcare regulations and payer guidelines. This includes analyzing and configuring benefit codes for medical,...

Compliance Specialist - BIS CertificationWe are seeking a skilled Compliance Specialist to assist our clients in obtaining the ISI Mark Scheme certification under the Bureau of Indian Standards (BIS). The specialist will play a key role in ensuring compliance with BIS standards for manufacturers and importers of products.Our goal is to help clients navigate...

Job Title: Financial ExpertWe are seeking a highly skilled and certified professional to fill this role.Key Responsibilities:Preparation of financial statements in compliance with regulatory requirements.Conduct audits ensuring adherence to compliance standards.Provide tax planning and advisory services, ensuring clients meet relevant taxation...