Regulatory Affairs Associate

POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

When our values align, there's no limit to what we can achieve. Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

Careers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and...

Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

Founded in 1920, Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a material way, Eastman works with customers to deliver innovative products and solutions while maintaining a commitment to safety and sustainability. The company's...

Responsibilities:Job Responsibilities:Assists in the planning, development, maintenance, and implementation of the SDS authoring process. Partners across all areas of expertise within the PSRA organization to monitor, promote, and deliver high quality, and fully compliant SDSs. Identifies key measures to assist in driving continuous improvements and...

Regulatory Affairs Consultant.8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute...

Regulatory Affairs Consultant.8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute...

Company DescriptionIQ-EQ is a leading Investor Services group which combines global expertise with an unwavering focus on client service delivery. We support fund managers, global companies, family offices and private clients operating worldwide.IQEQ is a preeminent service provider to the alternative asset industry. IQEQ works with managers in multiple...

Job Title: Regulatory AffairsSpecialistCompany:MakroCareLocation:Hyderabad Telangana(Onsite)CompanyDescription:MakroCare is aleading provider of regulatory and clinical development solutionsbased in Hyderabad Telangana. We specialize in offeringcomprehensive services in clinical research regulatory submissionsand scientific communication. Our team is...

CTD Dossier Drafting (Modules 2, 3, 4) Regulatory writing Clinical Regulatory & Pharmacovigilance Regulatory Regulatory commitment & compliance Any other Regulatory activities on need basis Support Line manager & Matrix manager in Regulatory projects Coordination and interaction with crossfunctional teamsMandatory SkillsEffective Regulatory/dossier writing...

JOB DETAILS 1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master FilesRegistration Dossiers & Technical Data Packages/OpenParts In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.Prepare responses to deficiency letters received from...

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible...

387199BRAssociate Medical Expert:IndiaAbout the roleAssociate Medical ExpertLocation - Hyderabad #LI HybridAbout the Role:The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues' requirements. He/ she is expected to support...

Job Title: RA US Injectable SpecialistAbout the Company: We are a leading pharmaceutical company dedicated to ensuring the quality and safety of injectable products manufactured in the US.Job Description:Understanding of the production and quality testing processes for sterile productsFamiliarity with the environmental factors crucial for sterile product...

Description Who is USP? The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of ...