Regulatory Affairs Associate
3 weeks ago
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 (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage Experience in handling CMC related health authority queries Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Preparation and review of Marketing Authorization Applications & Variations forvarious types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures). Preparation of documentation for different types of Variation procedures like Super grouping, Grouping and Work-sharing to the Marketing Authorizations. Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements. Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions Liaise closely with cross-functional members with aligned product responsibilities. Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates. Working experience in Regulatory Information Management Systems like Veeva Vault. Strong communications skills and ability to guide and mentor team members. Ability to work independently.-
Regulatory Affairs Associate
3 days ago
Hyderabad, Telangana, India Parexel Full timeHyderabad, IndiaJob ID R Category Regulatory / ConsultingABOUT THIS ROLE:Regulatory Affairs AssociateMust have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:Submission...
-
Regulatory Affairs Associate, Post-Approval
3 days ago
Hyderabad, Telangana, India SteriMax Inc. Full timePOSITION 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
3 days ago
Hyderabad, Telangana, India Parexel Full timeWhen 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...
-
Regulatory Affairs Specialist
3 days ago
Hyderabad, Telangana, India Medtronic Full timeCareers 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...
-
Senior Regulatory Affairs Associate
3 weeks ago
Hyderabad, Telangana, India Parexel Full timeRegulatory 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...
-
Senior Regulatory Affairs Associate
2 months ago
Hyderabad, Telangana, India Parexel Full timeRegulatory 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 Professional
3 days ago
Hyderabad, Telangana, India Eastman Full timeFounded 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...
-
Regulatory Affairs Professional
3 days ago
Hyderabad, Telangana, India Eastman Full timeResponsibilities: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
3 weeks ago
Hyderabad, Telangana, India Parexel Full timeRegulatory 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
2 months ago
Hyderabad, Telangana, India Parexel Full timeRegulatory 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...
-
Hyderabad, Telangana, India IQ-EQ Full timeCompany 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...
-
Regulatory Affairs Specialist
3 days ago
Hyderabad, Telangana, India Makro Full timeJob 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...
-
Regulatory Affairs Associate
3 days ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full timeCTD 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...
-
Hyderabad, Telangana, India Seven Consultancy Full timeJOB 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...
-
Regulatory Coordinator
3 days ago
Hyderabad, Telangana, India Novartis Full time26 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...
-
Associate Medical Expert
3 days ago
Hyderabad, Telangana, India Novartis Full time387199BRAssociate 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...
-
Regulatory Affairs Executive
3 days ago
Hyderabad, Telangana, India Hetero Full timeJob 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...
-
Senior Scientific Affairs Manager
3 days ago
Hyderabad, Telangana, India USP Full timeDescription 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 ...
-
Regulatory Innovation Associate
3 days ago
Hyderabad, Telangana, India Lifelancer Full timeAbout the job The Regulatory Innovation Associate plays a critical role in the development of regulatory services technology products to drive innovation and differentiation. Under general supervision, provides regulatory expertise and technical support for regulatory technology innovation initiatives. Essential Functions: Navigate through the Health...
-
Senior Scientific Affairs Manager
3 days ago
Hyderabad, Telangana, India US Pharmacopeia Full timeDescription 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 ...