Regulatory Affairs Associate
2 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.-
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...
-
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 Reporting Assurance
20 hours ago
Hyderabad, Telangana, India State Street Full timeBasic Purpose of Job: The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review...
-
Regulatory Reporting Assurance
4 weeks ago
Hyderabad, Telangana, India State Street Full timeBasic Purpose of Job:The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review...
-
Regulatory Reporting Assurance
4 weeks ago
Hyderabad, Telangana, India State Street Full timeBasic Purpose of Job:The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review...
-
Finance Change Delivery, Regulatory Reporting
3 hours ago
Hyderabad, Telangana, India State Street Full timeJob Background: Finance Change Delivery (FCD) is looking for seasoned Project Manager, who has experience with regulatory reporting and excellent financial industry knowledge. Should demonstrate excellent understanding of accounting and financials such as Balance Sheet, P&L, Capital calculation for entity, bank and/or branch reporting. Successful applicants...
-
Associate Buying Coordinator-
1 month ago
Hyderabad, Telangana, India Wells Fargo Full timeJob Requirements Job Title: Associate Buying CoordinatorCompany Name: Wells FargoLocation: Hyderabad, TelanganaSalary: ₹7,24,723 per yearEmployment Type: Full-timeJob Description:Wells Fargo is seeking an enthusiastic and detail-oriented Associate Buying Coordinator to join our team in Hyderabad. As an Associate Buying Coordinator, you will play a vital...
-
Financial Analysis Senior Advisor
3 weeks ago
Hyderabad, Telangana, India Evernorth Full timeFinancial Analysis Senior AdvisorPosition Overview:In collaboration with our Bangalore and US based Finance stakeholders and strategic partner ANSR for Business Support Services (BSS) in Hyderabad, the financial analysis senior advisor will have responsibility to oversee, track and report on the execution of the on-going BSS contract with ANSR. The contract...
-
R&D Project Manager II
3 weeks ago
Hyderabad, Telangana, India Thermo Fisher Scientific Full timeJob DescriptionRole & Responsibilities:As part of a multi-functional development team, major responsibility will include Project Management for the Temperature Control team.Lead medium to high complexity projects for Sustenance EngineeringCollaborate with extended team to facilitate execution and implementation of Revenue attainment (Obsolescence) and...
-
Platform Engineer
1 hour ago
Hyderabad, Telangana, India Inspire Brands Hyderabad Support Center Full timeResponsibilities:The Senior Cloud Services Engineer utilizes software that manages and monitors networks, systems and applications not only to guarantee performance to cloud software environments but also to better orchestrate and automate provisioning of resources.Build, manage and integrate software to automate and secure public cloud environmentsDevelop...
-
Software Quality and Test Engineer
3 weeks ago
Hyderabad, Telangana, India Parexel Full timeThe role will be accountable to validate and maintain the software quality within Corporate IT. This role will provide key inputs for validation during software development lifecycle (SDLC).Another key aspect of the role is the contribution to the continuous improvement of the function within the Scaled Agile Framework, and as such the role must be oriented...
-
Senior Analyst, Analytics
2 days ago
Hyderabad, Telangana, India Synchrony Full timeJob Description:Role Title : Senior Analyst, Analytics - Data StewardCompany Overview:With roots in consumer finance that trace back to 1932, Synchrony is a leader in consumer credit and promotional financing, providing a range of products for a diverse group of national and regional retailers in USA, including main street mainstays, local merchants,...
-
GEN AI Solution Architect
1 month ago
Hyderabad, Telangana, India Cognizant Technology Solutions Full timeRoleAssociate Director (Solutioning Lead)JOB DESCRIPTION Experience: Minimum 17+ years in technology development or automation, with a significant focus on AI and machine learning, and at least 5-7 years in business development, solutioning or client-facing roles within the technology sector. Role and Responsibilities• Develop and execute a comprehensive...
-
Regulatory Affairs Associate
5 days ago
Hyderabad, India Parexel Full timeHyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must 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...
-
Regulatory Affairs Associate
2 weeks ago
Hyderabad, India Parexel Full timeRegulatory Affairs AssociateAround 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 proceduresContribute to preparation...
-
Regulatory Affairs Associate
2 weeks ago
hyderabad, 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,...
-
Regulatory Affairs Associate
3 weeks ago
Hyderabad, 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 Associate
5 days ago
hyderabad, 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,...
-
Regulatory Affairs Associate
2 weeks ago
Hyderabad, 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...
-
Senior Regulatory Affairs Associate
1 month ago
Hyderabad, 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,...
-
Senior Regulatory Affairs Associate
4 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’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...
-
Senior Regulatory Affairs Associate
3 weeks ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’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...
-
Regulatory Affairs Executive
7 days ago
Hyderabad, India SFC Full timeHandling regulatory affairs in the pharma field. **Salary**: ₹200,000.00 - ₹600,000.00 per year **Benefits**: - Paid sick time - Paid time off Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Hyderabad, Telangana: Reliably commute or planning to relocate before starting work...
-
Regulatory Affairs Executive
5 days ago
Hyderabad, India Novick bio sciences pvt ltd Full time**We are hiring an Executive in Regulatory Affairs** **Qualification **:B. Pharmacy/M. Pharmacy (Pharmaceuticals) **Experience**: 3- 4 yrs. **Location **:Balanagar (Hyderabad) **Date**: 28/08/2023 TO 05/09/2023 (Mon to Fri) **Time ** : 10 AM TO 4 PM **Skills Required**: 2) Update the registration dossiers, evaluate queries received from respective...
-
Regulatory Affairs Executive
4 weeks ago
Hyderabad, India Shiva's Farma Casa Pvt Ltd Full timeLooking for a full time Regulatory Affairs executive with 1-3 years experience in APIs (Active pharmaceutical ingredients). No freshers. **Job Types**: Full-time, Regular / Permanent **Salary**: ₹200,000.00 - ₹980,116.12 per year **Benefits**: - Paid time off - Provident Fund Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability...
-
Regulatory Affairs Officer
4 weeks ago
Hyderabad, India Avasa Consultants Full timeHello Everyone, We are hiring for Senior Regulatory Affairs with 10+ Years of experience in API for Pharma company in Sadashivpet. **Job Types**: Full-time, Permanent **Salary**: ₹600,000.00 - ₹1,000,000.00 per year **Benefits**: - Provident Fund Schedule: - Morning shift Supplemental pay types: - Performance bonus - Yearly bonus Ability to...
-
Regulatory Affairs Consultant
4 weeks ago
Hyderabad, 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
4 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Lead and /...
-
Regulatory Affairs Consultant
3 weeks ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Consultant. 8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Lead and...
-
Regulatory Affairs Consultant
3 weeks ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. 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...
-
Regulatory Affairs Consultant
4 weeks ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. 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...
-
hyderabad, India IQ-EQ Full timeJob DescriptionResponsibilities The Senior Associate: Enterprise Risk and Regulatory Affairs will provide support: to the attainment of the overall objectives of the Enterprise Risk and Regulatory Affairs Department. in the planning, design and implementation of the enterprise-wide risk governance framework. to formulate regulatory and personal compliance...
-
Hyderabad, India IQ-EQ Full timeJob DescriptionResponsibilitiesThe Senior Associate: Enterprise Risk and Regulatory Affairs will provide support:to the attainment of the overall objectives of the Enterprise Risk and Regulatory Affairs Department.in the planning, design and implementation of the enterprise-wide risk governance framework.to formulate regulatory and personal compliance...