Senior Regulatory Affairs Specialist

Job Title:Senior Regulatory Affairs SpecialistAbout This Role:The successful candidate will lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.This includes overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.The individual will interface with...

About the RoleWe are seeking an experienced professional to manage 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 bodies.Main Responsibilities:Act as the primary...

Medical Device Regulatory Affairs SpecialistWe are seeking a skilled professional to fill this challenging role in the Medical Device Industry.The ideal candidate will have a strong understanding of quality systems and regulatory frameworks for medical devices, with hands-on experience with regulatory submissions, post-market surveillance, and risk...

Senior Food Regulatory SpecialistWe are seeking an experienced Senior Food Regulatory Specialist with strong expertise in international food regulations to join our team.Lead regulatory intelligence on domestic and export food labelling regulations across multiple markets (EU, US, UK, GCC, Canada, APAC, SE Asia, Latin America).Monitor, analyse and interpret...

Business Compliance Specialist OpportunityThis role involves managing the registration and ongoing regulatory compliance of businesses. The ideal candidate will have strong knowledge of federal and state compliance requirements, as well as experience in handling administrative and regulatory processes.Key Responsibilities:Assist clients with business entity...

Job OverviewWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.Main Responsibilities:Lifecycle Management (LCM) Support: Compile and review CTD dossier modules, prepare Variation documents, and evaluate post-approval CMC changes in compliance with global regulatory requirements.Initial Dossier Compilation:...

Insurance Compliance SpecialistThe role of Insurance Compliance Specialist is pivotal in ensuring our organization adheres to stringent regulatory requirements.Key Responsibilities:We are seeking a highly skilled and experienced individual to supervise and monitor insurance activities, guaranteeing all personnel are well-versed in insurance products.The...

Job Overview">We seek individuals who embody the highest standards of integrity, professionalism, respect, and a commitment to aligning personal ambition with the collective goals of the organization.">Designation: Assistant Vice President">Practice Area: Financial Regulatory Practice">Key Responsibilities:">Steer complex client engagements across regulatory...

Policy Strategist RoleAbout the Team:The Policy team plays a vital role in navigating regulatory environments and ensuring alignment with business goals within India's policy framework.The team collaborates closely with government bodies, regulatory departments, and stakeholders to achieve objectives.Responsibilities:Provide direction and guidance on policy...

Regulatory Change Monitoring SpecialistWe are seeking a highly skilled Regulatory Change Monitoring Specialist to join our team.About the Role:The Regulatory Change Monitoring Specialist will be responsible for designing and deploying an AI-driven Regulatory Horizon Scanning solution that leverages Artificial Intelligence, Natural Language Processing, and...