Regulatory Innovation Associate
3 weeks ago
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 authority (HA) websites and drug compendiums to procure multiple sets regulatory information based on the product development needs;
• Classify the regulatory data based on the scenarios to be evaluated;
• Perform through Quality Check (QC) of the digitized regulatory information/data;
• May perform manual comparisons between two or more documents or labels or document or label data sets to clearly demarcate the textual and contextual differences, highlight the medical and scientific keywords as per the agreed legends;
• Through Quality Check (QC) of system generated comparison outputs to identify and record the observations/undesired outcomes;
• Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content;
• Segregate, clarify and record all observations in systems like Application Lifecycle Management (ALM);
• Understand the business use case to author and execute User Acceptance Testing (UAT);
• Coordinate and liaise between Subject Matter Experts (SME) and Information Technology (IT) experts to execute and enhance the system functionalities;
• Provide input on interpretation and implementation of key regional regulations, guidelines, and best practices;
• Contribute to RADDS technology and continuous improvement initiatives;
• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
• May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
• May prepare and deliver trainings, as appropriate;
• Performs other tasks or assignments, as delegated by Regulatory management;
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
Preferred Skills:
• Understanding of global and country specific regulatory requirements across multiple regulatory activities such as MAAs, MATs, CMC, variations, etc.;
• Skilled In analyzing Medical and Scientific content in the Prescription and Patent Labels;
• Knowledge of global standards and regulations related to Registrations and Life cycle maintenance of Bio-pharmaceutical products;
Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req;
• Problem-solving ability with the ability to analyze risk and make appropriate recommendations/decisions;
• Well-versed with IT tools and processes. (i.e., IT tools like ALM, MS Excel, etc.);
• Minimum 2 years of pharmaceutical industry experience., inclusive of at least 1 year of regulatory and/or related experience;
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good interpersonal communication (oral and written) and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Regulatory Innovation Associate
2 weeks ago
hyderabad, 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...
-
Regulatory Affairs Associate
6 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, Telangana, India Parexel Full timeRegulatory 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
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
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,...
-
Regulatory Affairs Associate
7 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...
-
Regulatory Writer
1 month ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
-
Hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Associate Director, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders...
-
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, 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 Coordinator
1 month ago
Hyderabad, Telangana, India Novartis Full time394724BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...
-
Senior Regulatory Affairs Associate
1 month 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
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...
-
Consultant – Innovation Advisory
4 weeks ago
hyderabad, India Sathguru Management Consultants Full timePosition : Consultant – Innovation Advisory (Agrochemicals) Experience: Minimum 5 years Location : Hyderabad Key Responsibilities: About The Role : As an Agrochemical Specialist within Sathguru’s agri consultancy team, this techno-managerial role encompasses a comprehensive grasp of the latest advancements in technology and product innovations...
-
Consultant – Innovation Advisory
1 month ago
Hyderabad, India Sathguru Management Consultants Full timePosition : Consultant – Innovation Advisory (Agrochemicals) Experience: Minimum 5 years Location : Hyderabad Key Responsibilities: About The Role : As an Agrochemical Specialist within Sathguru’s agri consultancy team, this techno-managerial role encompasses a comprehensive grasp of the latest advancements in technology and product innovations...
-
Regulatory Reporting Assurance
2 days 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 Business Analyst
1 week ago
Hyderabad, India JPMorgan Chase & Co. Full timeYou are a strategic thinker passionate about driving solutions as a Business Analyst. You have found the right team.As a Business Analyst Professional in our Finance team you will spend each day defining, refining and delivering set goals for our firm.You will be r esponsible for gathering and documenting business requirement, in accordance with...
-
Regulatory Reporting Business Analyst
1 week ago
Hyderabad, India JPMorgan Chase & Co. Full timeYou are a strategic thinker passionate about driving solutions as a Business Analyst. You have found the right team. As a Business Analyst Professional in our Finance team you will spend each day defining, refining and delivering set goals for our firm. You will be r esponsible for gathering and documenting business requirement, in accordance with...
-
Global Program Regulatory Manager- LCM
1 month ago
hyderabad, India Novartis Full timeYour responsibilities include but not are limited to:• Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or...
