Regulatory Affairs Specialist

Job Summary:We are seeking an experienced Regulatory Affairs Professional to join our team.This role requires expertise in pharmaceutical and medical device regulatory compliance, including knowledge of FDA, EMA, CDSCO, MHRA, ISO 13485, and ICH guidelines.The ideal candidate will have experience with regulatory submissions, product lifecycle management, and...

Regulatory Affairs ProfessionalKey Responsibilities:Lead and Manage CMC Regulatory ActivitiesManage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee Compilation and Submission of ReportsCompile and submit Annual Reports, amendments, and deficiency responses.Interface with Cross-Functional TeamsInterface...

We are seeking an experienced and well-connected Senior Liaison Officer with over 15 years of experience in managing government relations, legal coordination, and regulatory affairs. The ideal candidate should have strong networking abilities with key stakeholders such as government departments, municipal authorities, legal professionals, and regulatory...

Senior Regulatory Affairs Specialist Job DescriptionKey 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...

Policy Strategy ManagerAbout the Role:We are seeking a skilled Policy Strategy Manager to provide strategic insights and recommendations on key policy matters.The role involves providing direction and guidance on policy strategies that align with business objectives. This includes representing the company's interests with regulatory bodies, industry...

Global Regulatory ExpertiseWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.Key Responsibilities:Prepare and Evaluate Regulatory Documents: Contribute to the compilation and review of regulatory documents, ensuring compliance with global regulatory requirements.Lifecycle Management: Assist in compiling and...

Job Title: Regulatory Compliance SpecialistThe primary focus of this role is on ensuring that our products meet regulatory requirements and comply with industry standards. A successful candidate will have hands-on experience in homologation and regulation.

We are hiring an experienced professional to represent our esteemed client in the Medical Device Industry.The position of Executive Quality Assurance and Regulatory Affairs requires 5-7 years of experience and a B.Pharm or M.Pharm degree from a recognized institution, with relevant experience in the Medical Device Industry.Key Responsibilities:Ensure...

Job DescriptionOur organization is seeking an experienced Regulatory Intelligence Specialist to support the development of an AI-driven regulatory change monitoring solution.This role focuses on leveraging Artificial Intelligence (AI), Natural Language Processing (NLP), and advanced analytics to automatically monitor, interpret, and analyze regulatory...

Regulatory Publishing Specialist for eCTD SubmissionsJob DescriptionAs a Regulatory Publishing Specialist, you will be responsible for managing BLA submissions and compiling regulatory documents in accordance with global health authority requirements.Manage the creation and publication of regulatory documentsPerform quality control on eCTD submissions to...