Regulatory Affairs Specialist

Regulatory Affairs SpecialistThe Regulatory Affairs Specialist role involves supporting the preparation and submission of regulatory documents for global markets. This includes preparing variation documents, evaluating post-approval CMC changes, and contributing to lifecycle management activities.Key Responsibilities:Compile initial dossiers (Modules 2 & 3)...

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...

Regulatory Affairs Expert We are seeking a seasoned professional to manage our legal and regulatory affairs. The successful candidate will be responsible for providing expert advice on commercial agreements, contract negotiation, and compliance with relevant regulations. Key Responsibilities: Advise on commercial agreements, including third-party contracts,...

**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...

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...

Role OverviewWe are seeking a seasoned professional to drive policy initiatives and manage activities in Food Regulatory Affairs.ResponsibilitiesCollaborate with government departments and engage with industry stakeholders to develop and implement effective policy strategies.Organize impactful initiatives, manage activities, and ensure seamless execution of...

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,...

Job Title:Regulatory Compliance Specialist Key Responsibilities: Prepare, review and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. Coordinate with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses and 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,...

Regulatory Specialist RoleKey to ensuring timely regulatory submissions, our Regulatory Specialist plays a vital role in compliance with relevant regulations. This includes submitting business proposals, schedules, and regulatory documents to the IRDAI portal, as well as tracking and aligning regulatory registers maintained by various business...