Regulatory Affairs Specialist

Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs 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...

Job Title: Regulatory Affairs SpecialistKey Responsibilities:Develop and oversee systems for regulatory compliance, licensing, and reporting.Establish and implement compliance frameworks aligned with food safety regulations.Provide strategic advice on regulatory matters across domains including Health, Safety, Environment, Food Safety, Pollution Control,...

Job Title: Global Regulatory Affairs Specialist">Job Summary: We are seeking an experienced Global Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for managing the regulatory affairs of our products in emerging markets.">Key Responsibilities:">"> Manage the registration process for our products in emerging...

Job Description:We are seeking an experienced Regulatory Affairs Specialist to operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet...

Regulatory Affairs Specialist: CMC AssociateWe are seeking a highly skilled Regulatory Affairs Specialist to support US FDA submissions and lifecycle management activities.Main Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

Regulatory Affairs Expert RoleMain Objectives of the Position:A highly skilled and knowledgeable professional contributor with in-depth knowledge in Regulatory Affairs. The position demands executing complex or specialized projects, adapting precedent, and developing innovative solutions to overcome traditional approaches.Key Responsibilities:Leads the...

Regulatory Affairs SpecialistOur ideal candidate will manage regulatory registrations, oversee certification renewal documents, and conduct internal audits.Job Description:Lead the management of REACH registrations across EU, Korea, Turkey, and UK, including tonnage upgrades and compliance letters.Handle customer inquiries and provide necessary declarations...

Job Title: Regulatory Affairs Expert">Job Summary:The role of the Regulatory Affairs Specialist is pivotal in ensuring timely and accurate execution of regulatory submissions, maintenance of product licenses, and coordination with Health Authorities (e.g., CDSCO, State FDA). The successful candidate will have a strong working knowledge of India's regulatory...

Job Description">We are seeking a skilled Regulatory Affairs professional to join our team. As a key member of our regulatory team, you will be responsible for the preparation and submission of registration dossiers, renewal applications, and variation applications for ANDA/ROW submissions.Key Responsibilities:Preparation and submission of registration...